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Johnny H
Posted on: Aug 5 2020, 04:36 PM


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Your ideas are intriguing, thought provoking, and above all, original. Do you have a website or newsletter that I can subscribe to????
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Johnny H
Posted on: Jun 30 2020, 03:02 AM


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Lots of things were promised.
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Johnny H
Posted on: Jun 27 2020, 01:01 AM


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I can't believe this is how management is spending their time. It's just further evidence that we were right all along.
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Johnny H
Posted on: Jun 25 2020, 07:36 AM


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"diary management" in a Melbourne based position? It sounds like they're anticipating TGA approval.
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Johnny H
Posted on: Jun 21 2020, 05:05 AM


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Wow.... The exclusion criterion there are.... substantial.

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Johnny H
Posted on: Jun 19 2020, 12:37 PM


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I don't think they'd be able to fully exit until FDA approval prices. We're talking shorts that are almost 10% of issue, which is probably almost 20% of float.


1st shorter out might be made whole; the rest are (insert profanity here)
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Johnny H
Posted on: Jun 19 2020, 12:03 PM


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Posts: 1,026

My thoughts, directed at no one in particular, and backed up by no evidence whatsoever:

The shorts are in some serious trouble. There were some very legitimate reasons to short in 2019. It looked like the US rollout was going to follow the pattern of the EU rollout, especially with the radio silence after approval, and then the statements suggesting treatments beginning "sometime" by the end of 2020.

The rollout wasn't as fast as I would have hoped, but it was certainly faster than most evidence-based investors would have expected.

The upwards trend in share price is obvious, and it cannot be contained. It seems that as soon as there is some upwards pressure on the share price, a few new shorts open to push the price back down. That doesn't work when there are over 4 million open short positions to be closed.

The shorters are now in competition with each other.... who is going to keep playing games, and who is going to get out clean? I'd be jumping ship right about now....

I bought 5000 shares today. I might do it again tomorrow. And the next day.

The brokers who shorted when the price was below 17 bucks? You're going to get fired.
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Johnny H
Posted on: Jun 18 2020, 09:58 AM


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For those of us poor suckers who are on 20 minute delay, please keep us posted. It's like watching the super bowl on DVR.
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Johnny H
Posted on: Jun 18 2020, 07:36 AM


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If this is correct, Clinuvel should issue a press release immediately.
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Johnny H
Posted on: Jun 13 2020, 12:47 PM


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I tried to find sales data for the number of prescriptions written for Photofrin in the US each year, but I came up short. Maybe one of you wizards could help me out.


If approved for PDT, Scenesse could be prescribed concomitantly with a significant number of Photofrin PDT treatments (as high as 100%, potentially) in the US each year.

Although historical data for Photofrin prescriptions gives us a good starting point, future projections are complicated by the fact that the main reason physicians avoid prescribing it is because of the severe phototoxic side effects. If Scenesse does in fact reduce or eliminate these side effects, one could expect that there would be a large increase in the number of Photofrin treatments each year.

While the revenue stream for Scenesse would be different for concomitant PDT versus EPP (a one off, single implant treatment vs 6 times a year for the patient's lifetime), I'd be curious to see if it would increase annual sales significantly. Again, I have no idea how often Photofrin is used, but at least 2 of the 3 FDA approved indications are NOT orphan.

One other bit of conjecture: it appears that MT-7117 is unlikely to compete with Scenesse for this particular indication. It takes too long to take effect. EPP patients are reporting photo protection as early as 3 days after getting the Scenesse implant, while MT-7117 takes several weeks for full effect (MT phase III trial compares baseline to week 26). Considering that PDT phototoxicity only lasts 30-60 days, MT-7117 would not be a good candidate.

This wasn't on my radar yesterday, but it sure is now. Clinuvel went to the trouble of registering a 10 year old trial for a reason, and this one makes the most sense.

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Johnny H
Posted on: Jun 13 2020, 08:22 AM


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Sounds like a pretty nasty treatment. What they're doing is basically inducing EPP in cancer patients by injecting porphyrins into the bloodstream, and then causing a targeted phototoxic reaction in the cancerous area by illuminating it with a laser.

The injection is followed by phototherapy 40-50 hours later.

For all intents and purposes, the patient has EPP for the next 30-90 days, and is extremely photosensitive.

It seems to me that this indication is similar enough to EPP that it could be approved with just a bridging study, and no human clinical trials would be required.
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Johnny H
Posted on: Jun 13 2020, 05:29 AM


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This is a big deal. You don't register a 10 year old clinical trial with clinicaltrials.gov unless you have a good reason to do so. A 10 year old trial would be in a completely different data format (data standards have changed at least twice since then, most recently 2 years ago), and it would take significant effort to prepare the data for submission. This would not have happened unless it was absolutely necessary.

Clinuvel is definitely going to use it for something, but the question is what.

Did the FDA ask them for photoprovocation data as part of the vitiligo package?

Or, is this for a completely new indication?
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Johnny H
Posted on: Jun 12 2020, 02:11 AM


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Figured it out. If you click on someone's user profile and select "send message", it will start you out with a blank message. From there, you can get to the inbox.
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Johnny H
Posted on: Jun 12 2020, 12:34 AM


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I see that I have a couple of IMs in my inbox, but when I try to go to my mailbox, I get an error. A week ago, I could get to them with my phone but not my laptop, and now I can't get to them at all.

If anyone would like to get ahold of me:
heckeljohn111@gmail.com
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Johnny H
Posted on: Jun 9 2020, 09:45 AM


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Not to be confused with Silicone Beach.


Palo Alto is also where Clinuvel's "US Director of Regulatory Affairs" was based until they got some office space up the freeway in Burlingame.
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Johnny H
Posted on: Jun 6 2020, 03:07 PM


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My earlier post notwithstanding, drug pricing is different in the US than elsewhere. Every drug has a cash price, sometimes called a "rack rate", which bears little resemblance to the actual price paid. The cash price exists for 2 reasons:

-to start as a negotiating point with payors (not to be confused with payers). If the cash price is X, the payor will demand a Y% discount. Insurance pays the negotiated rate, not the cash price. If the cash price is 40k, the insurance might pay 20k. Pricing in the US is NOT transparent, so nobody knows what each insurance company actually pays. Pricing contracts are closely guarded trade secrets.

-as an accounting reference used for write-offs for uncompensated care. For patients who have no insurance and no means to pay, generally, orphan drug companies will simply give the drug away at no cost to the patient and take a tax write-off for the cash price.

Insured patient: 20k in revenue

Uninsured patient: 40k in tax write-offs
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Johnny H
Posted on: Jun 5 2020, 10:32 AM


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This one seems to have some detail about what is required to bring a pediatric version of Scenesse to market.
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Johnny H
Posted on: Jun 3 2020, 03:10 PM


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I'll email both of you later.

Yet another WTF moment. My field of f@ks in which to give grows more barren each day.
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Johnny H
Posted on: Jun 3 2020, 11:24 AM


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Nothing like a Wally sociopolitical post with "photo protective, cancer preventative natural tan" sprinkled in.

I'm glad I had the chance to allow him to educate me. It was just what I needed.
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Johnny H
Posted on: Jun 3 2020, 12:25 AM


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I'm disappointed to see that a certain anti-shareholder screed remains posted. This kind of misinformation is absolutely unacceptable.

I've been understandably busy in the last few days, but I still managed to write up 5 more blurbs about Clinuvel's follies. I'd love to move forward, but it's not up to me.


Oh, and this time I'll be sending them to ASIC as well.
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Johnny H
Posted on: Jun 2 2020, 09:46 AM


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Not very useful information from what they've provided, as they only give the midpoint.

If they gave you the breakdown for long and short equity basket legs, you could infer the value by comparing it to the fixed (or in this case, floating) rate leg. More basis points added to LIBOR means the equity leg is worth more.

I'd be very surprised if there has ever been a swap with CLVLF as the equity leg. Very surprised. It's too easy to manipulate the outcome of the contract.
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Johnny H
Posted on: Jun 2 2020, 12:53 AM


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If it were any other company, I'd say vitiligo approval is a sure thing. But we're talking about Clinuvel here.

Clinuvel has a long and storied history of botching clinical trials. Even worse, when the FDA tells them what to do to gain approval, they don't do it. There's not really a point to having a Type C meeting if you're not going to listen to what the FDA has to say, In fact, it would be better to not have the meeting at all. That way, at least you're not insulting the people who are going to evaluate your drug application.


We have to wonder which Clinvuel we're going to get going forward. Is it going to be the flexible, transparent Clinuvel that we were promised? Or is it going to be the secretive, hubris-filled Clinuvel that takes decades to get things done because they won't learn from their mistakes?

I can think of a few ways they can signal to the market which path they're going to take....

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Johnny H
Posted on: Jun 1 2020, 07:01 AM


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Gross shorts have been averaging about 20,000 per day over the last week.

Last Friday:

QUOTE
CUV CLINUVEL PHARMACEUTICALS LIMITED FPO 130,520



So, if I'm understanding correctly, gross shorts mean any short shares that are party to a transaction, so the count includes any opening or closing of a short position.

Given that last Friday's gross shorts were about 6 times the moving average and the share price increased at close, I think it's safe to assume that someone has started closing out a significant short position. I wonder how they're going to exit their entire position without driving the price way up....
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Johnny H
Posted on: May 31 2020, 05:13 PM


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Well, I didn't want to do this, but here we are. I feel that we should all know what OUR company did.

Remember the longest review in EMA history? Where Clinuvel claimed to be the victim of an overzealous regulator?

Buckle up.

Clinuvel messed up the clinical trial so badly that their data showed that Scenesse doesn't work when it actually did.

After 2 AND HALF YEARS, Clinuvel finally got the corrected data from the trial to the EMA. Once the EMA got the data, it took them THREE MONTHS to approve.

Meanwhile, Wolgen released materially false information on the ASX about the "complexity of the review" and the "EMA requesting more time to evaluate".

The EMA was itching to approve, and broke its own rules, bending over backwards to get Scenesse approved.


The FDA story is even worse. I'll tell that story another time, but meanwhile, I'm being deployed for the next 12 hours to a war zone to quash riots. What kind of mood do you think I'll be in when the sun comes up, Clinuvel?

If you want to play games with your investors, I'm all in.





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Johnny H
Posted on: May 30 2020, 09:12 AM


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CLVLF is broker sponsored, as opposed to an ADR. (I don't know which broker). If the exchange rate adjusted share price is out of parity, it would be corrected by removing CLVLF shares from the US OTC market, and repatriating them to the ASX. The price is now out of parity, so if there is a correction, it will take place next week.

Each foreign-domestic stock is different, and the correction would be based on volume and transaction costs. CLVLF is very thinly traded and has high transaction costs, so it would be unlikely to see a correction until there is a 5-10% disparity in share price.

For a stock like Volkswagen (ADR in the US, 100k shares a day) you'd see a correction at 1-2%.


I don't think we'll see a cross-border correction as things stand now.
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Johnny H
Posted on: May 27 2020, 08:23 AM


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Scenesse Ads now showing up in google searches. Good to see.

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Johnny H
Posted on: May 27 2020, 08:19 AM


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Probably dozens of interactions to other drugs and even foods (ie grapefruit).

Another exclusion criteria for the trial is use of painkillers like Vicodin or any other opiates during or within 3 months of the start of the trial.


If I had a disease where it felt like boiling hot oil was poured onto my skin, there's no way I'd agree to that. Not a chance.
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Johnny H
Posted on: May 27 2020, 08:05 AM


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We've all theorized that there might be some liver and/or metabolism issues with MT-7117, as evidenced by their need to do a liver trial after completing Phase II.

Check out their exclusion criteria for the Phase III:

QUOTE
-Presence of clinically significant hepatobiliary disease based on LFT values at Screening.

-Subjects with AST, ALT, ALP ≥3.0 upper limit of normal (ULN) or total bilirubin >1.5 ULN at Screening.

-Subjects with or having a history (in the last 2 years) of excessive alcohol intake in the opinion of the Investigator.



It's starting to look like MT-7117 is nowhere near as safe as a peptide. Liver damage is no joke. The FDA might take issue with this given that there is already a safer treatment available, and, a subset of EPP patients already have known liver issues.
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Johnny H
Posted on: May 25 2020, 08:13 AM


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It can't. GoodRX gets those prices from one (or more) of the major PBMs (Pharmacy Benefits Manager) and then estimates the price based on existing contracts that various pharmacies have with the PBM. These PBMs do manage the prescription benefits for EPP patients, so the pricing is pretty accurate, although the availability information is not.
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Johnny H
Posted on: May 25 2020, 03:22 AM


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A sizable chunk of that goes to the provider for the procedure and back office costs (paperwork, insurance, billing, patient registry, post-marketing safety data collection, pre-procedure exam, cold storage, training, accreditation, etc). That's not to say that they aren't charging more; it's just hard to tell. Maybe Seeva could shed some light on it; he was the one who talked to Resnick's office directly.
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Johnny H
Posted on: May 22 2020, 08:32 AM


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Out of curiosity, I was browsing the TGA website to see if I could learn more about the approval process, and how long it might take. A couple of things of note:

-Since the TGA priority review program was implemented, Scenesse is one of only 31 one drugs to ever have been granted the designation by the TGA. This tells me that the TGA is serious about their priority reviews. The upload feature on Sharecafe is broken right now, so I can't post a screenshot. You can search "SCENESSE" here, and select "priority review". Scenesse received a priority review designation on October 24th, although Clinuvel didn't publicly announce it until a week later.

-TGA will accept reviews from international regulatory bodies
Use of international assessments: TGA may use international assessments to reduce the duplication of effort where an assessment has already been conducted outside Australia.. The FDA approval process is the most rigorous in the world, and the TGA uses the same application format and data standard (eCTD) as the FDA.

-TGA is part of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium
Essentially, a review by one of the member countries will be accepted by the other countries as valid. They even have a joint application process, whereby each of the countries will evaluate one module of the new drug application, and then come to joint decision for approval that is valid in each of the participating countries.

I was wondering why Wolgen had July 2020 listed on the TGA approval pathway in the latest newsletter (although his wording is vague and he makes up his own terminology), as my calculation had October at the earliest. I think I may have found my answer. Depending on how many of these policies can be applied to Clinuvel's situation, it could be even earlier.

In addition to accelerated approval in Australia, it could also mean quickly gaining approval in Canada and Singapore at minimal cost and effort. Here's hoping.

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Johnny H
Posted on: May 21 2020, 12:51 PM


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Click on his name and select "send message"
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Johnny H
Posted on: May 21 2020, 08:26 AM


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100% chance the author is a member of this forum.

It's nice to get the story out to a broader audience.
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Johnny H
Posted on: May 21 2020, 08:25 AM


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This is, by far, the best route for Clinuvel to go for Xeroderma Pigmentosum:

https://www.fda.gov/regulatory-information/...-enzyme-defects

And yes, Clinuvel knows about it because I told them a while ago.

I only know of 2 other companies developing orphan drugs under this guidance (one presented at UBS on Monday).

There are well established mouse models for XP, so it's a perfect candidate. Under this guidance, they wouldn't even need to conduct human clinical trials, especially with Scenesse already approved for another condition. It would be very fast, and very cheap.

And again, I would like to go on record as having told management about this a year ago. They can proceed however they see fit, but they can't claim they didn't know.
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Johnny H
Posted on: May 20 2020, 12:29 PM


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Expose patients to UV light, possibly with psoralen to increase thymine dimers, and then measure the results with and without afamelanotide. Could be a direct measure like comet, or it could be a surrogate endpoint like GG-NER protein concentration.
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Johnny H
Posted on: May 20 2020, 10:40 AM


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"New indication soon"

page 12
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Johnny H
Posted on: May 19 2020, 10:10 AM


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I liked this little tidbit:

"we have seen an expansion of payors and the first state insurance covering patients under Medicaid"

and this one:

"The clinical demand for SCENESSE® surpasses our expectations so far, the news reached us that more EPP patients are flying from all parts of the US to seek treatment."
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Johnny H
Posted on: May 18 2020, 02:11 PM


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I think we may have gotten our hint in the Clinhope/Seeva222 post below.

One trial with Scenesse+UVB, and one trial with Scenesse only. As a pooled study, the results are stronger than either trial alone. Scenesse+UVB has placebo/control issues; the controls know they're not getting an implant. Scenesse only has the unblinding and dropout issues; the patients know if they're the control, and when they are, they drop out because they don't want to have a mild surgical procedure for nothing.

Best case scenario is that Scenesse only works, as removing the UVB portion eliminates the biggest safety issue: a phototherapy that's known to be carcinogenic. That tips the risk/benefit strongly in favor, and makes sNDA approval a slam dunk. If S+UVB works slightly better, that's a decision between patients and their doctor.

My biggest hope here is that Clinuvel was listening very carefully when the FDA told them what to do.



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Johnny H
Posted on: May 17 2020, 08:06 AM


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I hope the newsletter takes a better tone than the Chair letter.
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Johnny H
Posted on: May 15 2020, 03:15 AM


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They're dealing with some runaway delays right now. I don't think they're going to start their Phase III until they get the results of the liver trial. In all likelihood, there were some safety signals from the PII that need to be addressed before the PIII can proceed.

I just checked the clinicaltrials.gov website, and the liver trial is pushed back yet again (the website has a history feature which shows the changes in record dates). The trial and study were scheduled to have been completed in November and December 2019, and now they're delayed, for the 3rd time, until October 2020.

The liver trial is still in the recruiting phase (I volunteered, haven't heard back), and the PIII hasn't even been posted yet. I don't see any way they can begin the PIII this year as their presentation suggests.




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Johnny H
Posted on: May 14 2020, 04:30 AM


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Attached is the current nationwide Anthem Blue Cross Blue Shield formulary, effective May 1st, 2020. Scenesse is covered under tier 3 (see page 147), and surprisingly, they do not appear to require prior authorization (which IS required for Vylessi coverage).

From Anthem Wikipedia Entry:
QUOTE
Anthem, Inc., is a provider of health insurance in the United States. It is the largest for-profit managed health care company in the Blue Cross Blue Shield Association. As of 2018, the company had approximately 40 million members.[2]

Anthem is ranked 33rd on the Fortune 500.[3]


From Blue Cross Blue Shield Wikipedia entry:
QUOTE
Blue Cross Blue Shield Association (BCBSA) is a federation of 36 separate United States health insurance companies that provide health insurance in the United States to more than 106 million people.[2]


I've seen Scenesse on every BCBS formulary I've checked. It's safe to assume that they all cover it (I got tired of checking), meaning that almost 1/3 of the entire United States population has prescription drug coverage for Scenesse through BCBS. To reiterate, not 1/3 of insured people; 1/3 of THE ENTIRE US POPULATION.
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Attached File  National_5_Tier_ABCBS.pdf ( 6.09MB ) Number of downloads: 45

 
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Johnny H
Posted on: May 12 2020, 01:13 PM


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Check your IMs for an answer to your EMA question.
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Johnny H
Posted on: May 12 2020, 07:59 AM


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The FDA didn't say no to the molecule; they said no to Epitan because Epitan didn't know how to properly file a coherent IND or design a valid clinical trial. 15 years later, they still didn't know how.

In case you aren't aware, the FDA disallowed one of the 2 clinical trials that Clinuvel submitted in the NDA because it was so full of errors as to be statistically invalid. 50% of their efficacy data package was summarily tossed, and this is after 8 years of delays to supposedly make corrections and perfect the data package in preparation for the NDA submission.

This, plus a number of other egregious errors, is why Wolgen had the FDA remove the Scenesse action package from the Drugs@FDA website for a "redaction review". A peek behind the curtain at Clinuvel's correspondence with the FDA makes them look absolutely horrible.


I thought we had moved on from all this, but apparently, Bjildorp would like to re-litigate it. How incredibly stupid of him.

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Johnny H
Posted on: May 11 2020, 04:51 PM


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I can't say that I'm enjoying the Bjildorp bounce.
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Johnny H
Posted on: May 10 2020, 12:30 PM


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Yep. Wolgen is unwilling to comply with the reporting requirements that come with a NASDAQ listing. You cannot run a publicly traded company the way Wolgen does and be listed on NASDAQ. One of the requirements is that all of the filings be truthful.

For perspective, a dual listing would probably net Wolgen maybe $50-100 million overnight. Maybe more. That he hasn't elected to do so tells you that the downside is pretty damn bad, and he has a healthy fear of the SEC.

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Johnny H
Posted on: May 8 2020, 03:30 PM


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In what universe is airing dirty laundry from 6 months ago part of a sound business strategy?

If the purpose of Bjildorp's letter was to deter criticism of management, it backfired horribly. Could not have gone worse.

It was an incredibly stupid and counterproductive move, and you have to wonder what in the hell he was thinking.

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Johnny H
Posted on: May 8 2020, 10:07 AM


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I can't say I'm thrilled with the letter. The tone detracts from Clinuvel's overall accomplishments.

It's exactly the sort of thing that would shake investor confidence and interrupt the ongoing rise in share price.

It comes across as defensive and thin-skinned, and lends the impression (especially to potential new investors) that they don't handle criticism well and will ignore the concerns of shareholders, no matter how legitimate. It would have been so easy to leave this out of the letter, but they didn't. It's unprofessional. No other company I've ever invested in publicly criticizes their shareholders, no matter how boorish their behavior.

This is the second time this tone has been taken in a Chairman's Letter. I hope it is the last.
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Johnny H
Posted on: May 8 2020, 09:43 AM


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Chair Letter to Shareholders:


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Attached File  44hnwzgfcmnfr7.pdf ( 147.79K ) Number of downloads: 221

 
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Johnny H
Posted on: May 8 2020, 05:16 AM


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I'm holding more shares now than ever before.

$45 share price with no US sales on the horizon? Overpriced.

$25 share price with US sales, Chinese sales, impending Australian sales, actively progressing US Vitiligo trials, global recession safe harbor, enough cash on hand for 5+ years of operating costs, and expanding Singapore labs for R&D? Massively underpriced.
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Johnny H
Posted on: May 4 2020, 11:57 AM


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The first annual Uho memorial prize goes to.....
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Johnny H
Posted on: May 3 2020, 03:06 AM


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"The company is set to release the first of its “Chivere” trademarked products as early as 2020."

Lagoda probably gets more information here than from any other source.
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Johnny H
Posted on: May 1 2020, 02:56 PM


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Oh, and everyone is buying.
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Johnny H
Posted on: May 1 2020, 02:52 PM


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Almost 100,000 shorts closed out over the last 2 trading days for which data is available.
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Johnny H
Posted on: May 1 2020, 01:30 PM


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Next time you come to town, I'll break my no drinking rule.

We can both be right and each buy a round.
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Johnny H
Posted on: May 1 2020, 12:02 PM


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FDA Helps Streamline Approval Process for Supplemental Drug Indications

QUOTE
For example, said Dr. McKee, daratumumab (Darzalex) was first approved for multiple myeloma in November 2015; a supplemental new drug application for another indication showed similar response rates, resulting in a second approval 1 year later—and a third only 7 months after that.
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Johnny H
Posted on: May 1 2020, 10:20 AM


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4 out of the 5 modules in the (s)NDA are already completed and accepted by the FDA.

It's just a matter of getting the (hopefully self-funded) trial done and submitting the data.
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Johnny H
Posted on: May 1 2020, 09:46 AM


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"Following this meeting the FDA, clinical experts and CLINUVEL will finalise the documentation and clinical trial protocol (CUV104) to advance SCENESSE® as the first systemic repigmentation agent in North America."

Sounds like the FDA had some suggestions. Good thing they had this meeting before running the trial.

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Johnny H
Posted on: May 1 2020, 06:55 AM


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No need once the topical is available. You put it on, it works, and there's minimal exposure to the rest of the body, including the liver.
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Johnny H
Posted on: Apr 29 2020, 03:11 AM


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Thanks. Farma is pretty good with his research, so a type C could be different than a type B.

If they do have to wait for the official minutes, I think it would be reasonable to expect them to release some information in the interim.

Unrelated: I do hope they're using something more professional than Zoom for this meeting.

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Johnny H
Posted on: Apr 29 2020, 02:46 AM


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For their last FDA meeting, a type B, the results of the meeting were released a day after the meeting took place.

In Oct 2016, they announced that the meeting would take place on Nov 7, and provided the results on Nov 9 (1 day later when taking into account the international date line).

Most likely, we'll hear something before the end of this week. I'm not sure I can handle any more good news; I'm starting to get chafed.
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Johnny H
Posted on: Apr 28 2020, 10:55 AM


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Seeing as how Clinvuel is trying to take IR more seriously now, I'd love to see a press release about the outcome of the meeting. Nothing with commercial secrets, obviously.

Something alone the lines of "Clinuvel and FDA agree on primary endpoints to advance Scenesse for treatment of Vitiligo"

Meeting is in 2 days; they should have something ready to release on Thursday market open.

If Clinuvel requests and receives a Special Protocol Assessment from the FDA, they should announce it to the market immediately. SPAs are binding on the FDA, meaning they have to accept the results of the trial.

More about SPAs attached.
Attached File(s)
Attached File  Special_Protocol_Assessment_Guidance_for_Industry.pdf ( 181.98K ) Number of downloads: 847

 
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Johnny H
Posted on: Apr 28 2020, 09:22 AM


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Quarterly out.

$5.37 million cash receipts.
Cash on hand increased $4,894,000
Cash equivalents $62,329,000

For a company in the process of a massive expansion, this is a pleasant surprise.
Attached File(s)
Attached File  44h9fbybw6jbfs.pdf ( 336.27K ) Number of downloads: 185

 
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Johnny H
Posted on: Apr 28 2020, 02:15 AM


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I wonder if PREnumbra is an indication that it's supposed to be preventative.
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Johnny H
Posted on: Apr 27 2020, 11:42 AM


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It's a combination of
-hemosiderin staining (normally limited to the lower legs, but can affect the whole body if you're bedridden)
and
-Anti-malarial induced hyperpigmentation, a known dermatological side effect (25%) of the anti-malarials hydroxychloroquine. Counterintuitively, this is actually a form of depigmentation.
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Johnny H
Posted on: Apr 27 2020, 03:57 AM


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Which state?

The 3 states where I have a liability are all July 15th.
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Johnny H
Posted on: Apr 26 2020, 02:26 PM


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I've had this issue several times.

What you're describing is "covered shares" vs. non-covered shares. Any shares purchased after December 31, 2011 are covered. That means that your broker is required to track the cost basis and report it to the IRS. If your tax return shows something different than what your broker is reporting for the sale of covered shares, expect it to draw attention.

For any shares purchased prior to that date (non-covered shares), your brokerage does not (or, is not required to) track the cost basis. The only thing that your brokerage reports to the IRS is the proceeds from the sale. If you sold any shares of Clinuvel in 2019 that are non-covered, the burden is on you to dig through the boxes in your closet to find your brokerage statements from 2008 and provide the cost basis yourself. However, the IRS only reasonably expects you to have 7 years of records, so, for a purchase in 2008, they will generally take a good faith, reasonable estimate.

Long story short, don't do things that will get you audited, and make sure your tax software acknowledges that you have long term capital gains. Short term CGs get taxed at your marginal rate.

Personally, I'm not paying until July 14th. I owe mid 6 figures, and I'd rather have that money in Clinuvel for 3 months than give it to the IRS now.
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Johnny H
Posted on: Apr 24 2020, 10:27 AM


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Apologies if this has already been posted. There were a flurry of posts around the China expansion and I haven't gotten around to reading all of them yet.


Financial Times 2020 rankings for the top 500 high growth Asia-Pacific companies:
https://www.ft.com/high-growth-asia-pacific-ranking-2020

Clinuvel at a respectable #79.




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Johnny H
Posted on: Apr 24 2020, 05:44 AM


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He also used the term "standard of care", as opposed to a clinical trial, experimental treatment, or a compassionate use scheme. Standard of care implies a commercially available treatment which has been approved by regulators.


If this is their way of making it public, it wouldn't be the first time that they've released privileged information through Pink Sheet.
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Johnny H
Posted on: Apr 23 2020, 12:57 PM


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I hesitate to go down this road, but would somebody mind posting the Level 2/Book Depth?

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Johnny H
Posted on: Apr 23 2020, 10:14 AM


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It was confirmed via a phone call to Dr. Reznik's office last week.
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Johnny H
Posted on: Apr 23 2020, 09:39 AM


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Great news. And, Clinuvel is in a good position in re: medical piracy. The implant manufacturing process is secretive, and there's only one place that can do it.

With regard to the 5000 patients, I think it could turn out to be a lot more. Everything is under-diagnosed in China, plus they have 1.4 Billion people. I'm mostly curious about the reimbursement process.


Edit*

There was a second announcement and it tells me that I'm not going to get an answer to my question.

"The commercial terms of the collaboration have not been disclosed."

On the plus side, the second announcement is labeled price sensitive.
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Johnny H
Posted on: Apr 23 2020, 09:28 AM


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CLINUVEL STARTS SCENESSE® SUPPLY INTO CHINA
Attached File(s)
Attached File  CUV_CLINUVEL_starts_SCENESSE_supply_into_China.pdf ( 221.36K ) Number of downloads: 185

 
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Johnny H
Posted on: Apr 22 2020, 10:33 AM


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Yep. Every implant comes in its own jar (and box). As soon as you pop the PTFE stopper, you have to use it or throw it away.

But... what if you didn't actually throw it away....
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Johnny H
Posted on: Apr 22 2020, 07:12 AM


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I missed this bit when I glanced over the SMALLCAP World Fund yesterday. This fund holds 941,000 shares of Clinuvel as of 3 weeks ago.

QUOTE
As one of our most research-intensive strategies, with a team of more than 100 portfolio managers and analysts based in both developed and developing markets, it takes full advantage of our global presence and insights.


https://www.capitalgroup.com/advisor/investments/fund/smcfx
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Johnny H
Posted on: Apr 22 2020, 02:01 AM


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"The skin colour change is being put down to a hormonal imbalance that took place as the doctors’ livers were damaged by the virus, Chinese state media reports."

Plainly untrue. Their skin would be yellow, not pigmented. The whites of their eyes would also be yellow, and that's clearly not the case in that picture.

There's a chance that it's not the implant, though. China manufactures the API in bulk, and they're not exactly big proponents of intellectual property laws. If this is the case, I can see why Clinuvel would not want to publicize it.
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Johnny H
Posted on: Apr 22 2020, 01:52 AM


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New Clinuvel website. Combing through it right now, will report back.

http://www.epp.care
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Johnny H
Posted on: Apr 21 2020, 09:09 AM


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Just an FYI, Avita is already traded on NASDAQ.

In the Chair letter, Bjildorp indicated that Clinuvel will not be re-domiciling anytime in the near future, but is silent on the question of a dual listing.

A dual listing on NASDAQ would be pretty simple for Clinuvel, but they haven't had anything more than a post office box stateside up until 2 weeks ago. Now that they have a physical presence, I don't know what's stopping them.
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Johnny H
Posted on: Apr 21 2020, 02:36 AM


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They're exactly who we want. See page 11 of attached:

QUOTE
Capital Research and Management Company maintains an investment philosophy that is distinguished by four key beliefs:

• Solid research is fundamental to sound investment decisions. Capital Research and Management Company employs teams of experienced analysts who regularly gather in- depth, first-hand information on markets and companies around the globe.

• Investment decisions should not be made lightly. In addition to providing extensive research, our investment professionals go to great lengths to determine the difference between the fundamental value of a company and its price in the marketplace.

• A long-term approach. It's part of the big-picture view our investment professionals take of the companies in which we invest. This is reflected by the typically low turnover of portfolio holdings in the funds we manage. In addition, our investment professionals usually remain with us for many years and are compensated according to their investment results over time.

Attached File(s)
Attached File  Capital_Group_Adv.pdf ( 927.55K ) Number of downloads: 1050

 
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Johnny H
Posted on: Apr 20 2020, 10:34 AM


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We're a billion dollar company again.

It felt better the first time, but this time the valuation is on much more solid ground.
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Johnny H
Posted on: Apr 20 2020, 07:04 AM


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They're claiming direct shipment.


Although, in Clinuvel speak, this could mean "real estate agent with a beer cooler in a U-Haul".
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Johnny H
Posted on: Apr 20 2020, 06:13 AM


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CPT 17999 and/or J3490.

I think the big money comes from "consultation" or "case management" fees.

Resnik is charging $20k on top of the cost of the implant. Of course, that's the cash rate, and nobody pays the cash rate. In-network payout is probably less than 10% of that, which is still very worthwhile for HCPs.

As stated by Seeva below, EU providers get paid almost nothing to administer the implant, so doing them is probably not a priority. I've even heard that some centers actually lose money on each patient. Fortunately, we'll have no such problems here.

It would be a wise business decision to get on the Scenesse train before it leaves the station. I've tried to talk a few derms into doing it, and they're very interested; especially the one who specializes in cosmetic procedures. Her business has taken quite a hit because of the virus.

I think that a few years from now, we'll have even more "specialty centers" in the US than Clinuvel had originally planned.
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Johnny H
Posted on: Apr 20 2020, 05:10 AM


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Half of that goes to the doctor. The doctors might be able to get away with it now, when there are only 3 centers open, but I imagine that the price will come down quite a bit as more centers open.

In a competitive market, a 30 minute procedure (28 minutes of it observation) with minimal liability attached does not cost 20k.
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Johnny H
Posted on: Apr 18 2020, 03:27 AM


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Strong demand on the buy side. It's been a long time since I've seen this.
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Johnny H
Posted on: Apr 17 2020, 10:48 AM


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Clinuvel's FDA type C meeting is in 2 weeks.

Hopefully it goes smoothly, as they're meeting with the same FDA staff who reviewed the original NDA.

I wouldn't expect there to be any delays due to COVID; the FDA loves videoconferencing.
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Johnny H
Posted on: Apr 17 2020, 08:38 AM


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"Speculative Buy" is the understatement of the decade.
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Johnny H
Posted on: Apr 17 2020, 06:12 AM


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The controlled distribution makes a lot more sense to me now. The doctors are obviously very.... enthusiastic about Scenesse for a variety of treatments. I have no doubt that they would prescribe off label right now if they were allowed.

Clinuvel needs to prevent it just long enough to get vitiligo approved, and then they can open the floodgates.

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Johnny H
Posted on: Apr 17 2020, 05:57 AM


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Interesting. All 3 centers specialize in dermatology, and not metabolic disorders like EPP.

This should make the eventual transition to vitiligo patients much smoother. This is a good sign for future business.
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Johnny H
Posted on: Apr 16 2020, 02:41 AM


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Phone call (not me). It's important to note that some of the patients who have prior authorization were previously traveling to Switzerland, so there might be a slight decline there.
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Johnny H
Posted on: Apr 16 2020, 01:59 AM


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Resnick has 10 patients in the queue so far. Not sure how many he'll get to this month, but probably most.

The other doctors are a little more publicity shy, so who knows how many patients they have so far....

I expect that as the lockdown loosens, we'll see more and more treatments, and hopefully we'll be running full speed by the end of June....

I'd love to see a news release from Clinuvel sometime this week.
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Johnny H
Posted on: Apr 15 2020, 05:21 AM


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OK, so, San Diego messaged me with a really good question, and after looking into it, I think I have a definitive answer.

Where were they in the trial, and had it already started? I didn't think it had started, but what if they were doing an unregistered trial to maintain commercial secrecy?


Long story short, they can't. It's illegal as of 2007. If they intend to apply to the FDA for market authorization, or, if any portion of the trial takes place inside the states or territories of the US, they MUST register the trial within 21 days of enrolling the first patient. "Enrolling" is when the patient signs the Informed Consent and agrees to participate in the trial, not when the trial actually begins.

As of right now, there is still no Phase III MT-7117 trial registered with clinicaltrials.gov.

Based on this, the phase III trial was suspended while it was still in the pre-recruiting phase.

Scenesse head start confirmed.


QUOTE
§11.24 When must clinical trial registration information be submitted?
(a) General. Except as provided in paragraph (b) of this section, the responsible party for an applicable clinical trial for which submission of clinical trial registration information is required must submit the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or §11.28(a), as applicable, not later than December 26, 2007, or 21 calendar days after the first human subject is enrolled, whichever date is later.
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Johnny H
Posted on: Apr 15 2020, 02:59 AM


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It appears that Mitsubishi Tanabe's EPP trial is suspended until further notice.
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Johnny H
Posted on: Apr 14 2020, 10:33 AM


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Additional health plans covering Scenesse:

https://www.coordinatedcarehealth.com/conte...amelanotide.pdf

https://www.deancare.com/getmedia/2575884f-...02.pdf?ext=.pdf

https://pharmacy.envolvehealth.com/content/...%2003.01.20.pdf

https://uhahealth.com/uploads/forms/list-of...-require-pa.pdf

https://formularysearch.caremark.com/formul...ftsByDrug_3.pdf (NTM status, not excluded)

https://content.highmarkprc.com/Files/Regio...2020-010820.pdf (effective immediately)

https://www.trilliumohp.com/newsroom/RxUpdateQ1-2020.html (effective Q1 2020)

https://www.premera.com/medicalpolicies/5.01.605.pdf (effective April 1, 2020)

https://providers.bcbsal.org/portal/documen...67-65d42d6abf8e (effective Feb 2020)

https://www.bluecrossmn.com/sites/default/f...20Summary_0.pdf (effective April 6 2020)

https://wa.kaiserpermanente.org/static/pdf/...3-formulary.pdf (Effective April 2020)


The last one, Kaiser, is a big one, BTW.
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Johnny H
Posted on: Apr 7 2020, 11:15 AM


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Given that the announcements are in Clinuvelspeak, there is some ambiguity and they can be interpreted either way.

"During the first phase of distribution commencing 15 April 2020, patients will be able to receive treatment under Prior Authorization [PA]."

So it's certainly possible that they could administer the first US implant on the 15th.

As far as the delays for paperwork:

"In total 29 insurance companies across 16 states have so far agreed to SCENESSE® therapy under PA (prior authorization)"

Given that they have already agreed to it, I read this as meaning that patients with these insurance companies could obtain verification right now, and the doctor could have the PA paperwork completed and submitted prior to the 15th.

I'm not saying it's definitely going to happen, but it's certainly possible. It would be kind of disappointing if the long anticipated launch date is kicked off with paperwork rather than an actual treatment.


On another note, while looking through the announcements, this jumped out at me:

"prescribing physician required to agree treatment of patients for 1 year under PA"

Interesting that doctors are required to agree to a year of treatments. It's beneficial to Clinuvel and EPP patients for a number of reasons.
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Johnny H
Posted on: Apr 6 2020, 05:09 AM


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The formulary is a master list of prescription drugs that an insurance plan will cover, and the different tiers for copay.

Usually, the insurance plan will only drop a drug from their formulary if there is a cheaper and more effective medication for the same indication.

In the case of desonide, it's almost $200 per tube, which is pretty expensive for a Class VI (weak) steroid.


As a drug treating an orphan condition with a previously unmet medical need, Scenesse does not have any alternatives, affordable or otherwise.

Insurance companies will do what they can to drag their feet, but in the end, they'll end up covering Scenesse. If they drag their feet long enough that a patient takes them to arbitration for denying coverage, they'll lose. The FDA approved Scenesse as a once every 60 days treatment for EPP, and that's what the insurance companies are going to end up paying for. US private insurance doesn't have European style rationing; they can't decide to cover less than the indicated number of treatments (6 per year) because of the cost. This is especially true because EPP is a chronic condition; the insurance company can't deem you "cured" or decide that there's no further benefit to additional treatments (which they CAN do for certain very expensive chemotherapies).

I think that the most likely explanation here is that Dr. Resnick made the webpage a long time ago, and the information is not current. I have no doubt that he'll be doing 6 implants per year if it's what the patient requests.
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Johnny H
Posted on: Apr 5 2020, 03:23 AM


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I'm supposed to be at the JW in Aventura right now.

Cancelled due to the plague.
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Johnny H
Posted on: Apr 5 2020, 03:21 AM


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If it goes from positive to negative?
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Johnny H
Posted on: Apr 3 2020, 12:24 PM


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Scenesse was registered on the NDC list with a marketing start date of December 31, 2019. In theory, US patients could have been treated any time after that date. I'm curious to find out if they did treat any patients outside of the regular distribution channels while they were trying to set up the 3 specialty centers. At least one EPP patient has stated publicly that he was promised a free dose for participating in the clinical trials....
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Johnny H
Posted on: Apr 3 2020, 06:05 AM


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I can't see this company selling anything other than MSH derived pigmentation products. Anyone can produce a dihydroxyacetone based cream, but it looks like crap and isn't photoprotective.

I would be very disappointed if Clinuvel tried to market a DHA based sunless tanner.
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Johnny H
Posted on: Apr 3 2020, 02:09 AM


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Clinuvel has described one of the topicals as a "maintenance therapy" for vitiligo.

If this is in fact a hair coloring treatment, perhaps it does so "naturally" by increasing the melanin production capabilities of the hair follicle.

If so, then this would be consistent with a vitiligo therapy. Repigmentation begins at the hair follicle, and slowly migrates to the rest of the skin.
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Johnny H
Posted on: Apr 2 2020, 05:45 AM


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Call me a cynic, but I think Citi is heavily involved. I don't have any evidence to back this up, but the timing is too perfect to be a coincidence.

They only issued warrants on the long side, effectively taking a short position. In taking such a position, the reward is limited (share price can't go lower than zero), but the risk is unlimited. They had every incentive to drive down the share price.

Right around the time they issued the warrants, the share price started a steady decline and shorts starting increasing.

And what do you know? Every single warrant they issued got knocked out; even the ones nobody thought possible. To the outsider, given enough time, it appeared that there was no way they could make money on any of the warrants with the lower strike prices (D series and below). And yet, they made the maximum profit possible on every single one.

Now that all of the warrants are knocked out, the share price is going back up.

This is not a coincidence.

Citi took a long shot with unlimited risk, which is something that nobody would ever do on a level playing field. They knew they had a sure thing.

At least it's over now.

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Johnny H
Posted on: Apr 1 2020, 12:56 PM


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Management is responsible for a lot of things, but not shorting. I'd give it a rest.
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Johnny H
Posted on: Apr 1 2020, 09:08 AM


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Last month, that would have frustrated me, but with the upcoming US rollout, it's relatively unimportant from a business standpoint.

2 weeks.

Two. Weeks.
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Johnny H
Posted on: Mar 31 2020, 09:32 AM


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If I were in charge of investor relations, which I'm not, I'd clarify the situation around VLRX002. The first (and only) mention of it I can find after a quick google search is the 2019 AGM.

If they have another drug in the pipeline, they should publicize it. I follow this company very closely, and I didn't even notice it until now.

A 50% increase in drugs in the pipeline is kind of a big deal, and could be a major factor in the future financial success of this company. The market needs to be informed about it.
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Johnny H
Posted on: Mar 31 2020, 05:03 AM


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I was under the impression that Phimelanotide was CUV9900, but they have it as "VLRX002".


Does this mean that they have 3 small peptide melanocortins in the pipeline?
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Johnny H
Posted on: Mar 29 2020, 04:50 AM


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Clinuvel deliberately coded Scenesse implantation as a medical procedure, and not a pharmacy benefit.

Health insurance medical benefits are generally far more generous than pharmacy benefits, especially with regard to specialty drugs. The deductible is easier to hit too.

This is the second good decision I've seen out of them in less than a month. It feels weird.
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Johnny H
Posted on: Mar 27 2020, 10:20 AM


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IIRC, he deleted a comment about it too. Shady.
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Johnny H
Posted on: Mar 25 2020, 09:35 AM


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A lot of people put their money elsewhere because there wasn't going to be any US revenue for another 9 months. Expectations were low. There was absolutely no hurry to buy in before then, and now there is. We're 21 days from launch.

Health insurance companies are somewhat insulated from economic downturns. If people don't pay for coverage, they don't get coverage. The money in/out equation doesn't change.


Clinuvel's sales will not be affected by coronavirus. Comparatively, this puts them in a much better position than almost all other companies.

A month ago, Clinuvel was a bad investment because of the opportunity cost. Now, it's a safe place to put your money.

Anything is possible, and the share price could go down again, but expect a long term trend upwards as we approach the launch date.
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Johnny H
Posted on: Mar 25 2020, 03:56 AM


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I had some cash set aside for taxes, but the filing date is pushed back to July 15th. July 15th is 3 months after US commercial launch, so I figure it's a good place to park the money.

I don't think it was in Clinuvel's initial plan to do a partial rollout in only 3 centers, so it seems that they've been responsive to criticism from patients and shareholders.

Patients who are willing to travel to one of the 3 centers for treatment are the same patients who are likely to volunteer for clinical trials, so strategically, this was the right move: begin treating patients even if the complete infrastructure isn't in place yet.

I've been rabble rousing about this for months, and it's finally happening. Late is better than extremely late.
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Johnny H
Posted on: Mar 25 2020, 02:27 AM


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2/3rds of that was me.

I think we've seen the bottom. Alleged sales in less than a month.
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Johnny H
Posted on: Mar 25 2020, 01:50 AM


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Before anyone jumps to conclusions, that was me.
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Johnny H
Posted on: Mar 24 2020, 12:27 AM


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Clinuvel confirmed the cities in which the initial 3 specialty centers will be located:

Los Angeles, Detroit, and Aventura, FL.

In Los Angeles, the center is located on the UCLA campus.

In Miami (Aventura), the location is here.

Any guesses on the Detroit location? (My guess is Henry Lim, but I haven't found anything to confirm it)
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Johnny H
Posted on: Mar 20 2020, 09:21 AM


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I have Plaquenil lying around for me and my family for exactly this reason.

Also.... get pneumovax. Doesn't matter if you think you're too young for it. It can only help.
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Johnny H
Posted on: Mar 19 2020, 11:49 AM


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2 pages on the Coronavirus with no mention of Scenesse as a potential treatment.
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Johnny H
Posted on: Mar 17 2020, 11:48 AM


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Unfortunately, I don't think they can right now. There's only enough stock to treat a small number of patients for an extremely rare disease.

Scenesse has a refrigerated shelf life of 48 months. Clinuvel probably does a limited production run every 2 years to control costs, and, most likely, they haven't even done the production run for US distribution yet.

At the very least, though, Wolgen should inquire about the possibility of helping during this crisis, and should publicly state Clinuvel's willingness to do so. If Scenesse actually works for Covid and can save lives, they should begin production immediately and make it widely available.

It's impossible to overstate the amount of goodwill Clinuvel would earn from the public by doing something like this.
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Johnny H
Posted on: Mar 17 2020, 02:17 AM


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Are you using Android? I was told that it works on computers, and possibly iPhones, but possibly not on other mobile devices.
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Johnny H
Posted on: Mar 14 2020, 03:36 AM


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Question for the Aussie finance/accounting guys:

If ASIC bans shorting, does that only apply to future trades, or will traders be required to close out existing shorts?


I don't know what the answer is, but I sure know what I want it to be.
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Johnny H
Posted on: Mar 14 2020, 03:08 AM


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Since alpha MSH's antiviral properties are at the 11-13 position, and afamelanotide Nle Phe substitutions are at the 4,7 positions, in theory.... afamelanotide should have the same effect.
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Johnny H
Posted on: Mar 13 2020, 09:00 AM


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Posts: 1,026

Long term plan: The panic is going to get worse over the next month or two. And then, suddenly, people will realize that there was a huge overreaction. The market will take off like a rocket. Be ready to have your chips on the table.

At least in the United States, the panic and overreaction is driven by lawyers, not doctors. My wife, a corporate attorney, banned all business travel and meetings for her company, and it wasn't for the safety of the employees. It's to protect the company from liability.

At least some portion of the workforce is going to get coronavirus. That is a fact, and it is unavoidable. There's a 50/50 chance that I'll get it, and if so, I'd prefer to get it out of the way sooner rather than later. For most of us, it will be less than a week of downtime (Billy Boots likely the exception, Rest In Peace), and another week of isolation. That's it.

Of the portion of the population who does contract the virus, no business wants to be to blame for it. If there was a history of business travel, the company is on the hook for workers compensation payments. If someone went to Disneyland or an NBA game or a concert and later contracted the virus, they could sue the venue and its owners. It's much cheaper to cancel events than to hold them as scheduled. To continue business as usual means exposure to massive liabilities.

All of the shutdowns and ensuing panic are the result of business decisions, and are not representative of the danger of the virus itself.

A month or two from now, when we have more information, potential treatments and vaccines, and a better handle on the epidemiology of the virus, we'll realize what an overreaction this whole thing was.

Be ready to buy. Not now, but soon.
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Johnny H
Posted on: Mar 13 2020, 02:32 AM


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The infographic makes it pretty clear that corporate is staying in Australia, and there won't be a NASDAQ listing.
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Johnny H
Posted on: Mar 12 2020, 03:39 AM


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Looks like it's part of a basket for a mutual fund. The question is: was the fund buying or selling?
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Johnny H
Posted on: Mar 6 2020, 11:10 AM


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MT-7117's phase 2 trial was only 16 weeks of treatment. In theory, patients could participate and complete the next trial before Scenesse ever becomes available.

This is one of the reasons I'm disgusted beyond words at the pace of Clinvuel's rollout. If they begin treating the US population before Mitsubishi's phase 3 starts, it effectively locks MT out of the US market for years to come. MT would have to do the Phase 3 in Japan, and then would be required to do a bridging study because of differences in the ethnicity of the target patient population.

Since Clinuvel has set the ridiculously low bar of having their permanent distribution system up and running by the end of 2020, they need something temporary to fill in the gap. Right now, there's nothing stopping Clinuvel from hiring a traveling doctor (and medical records assistant) to tour the country administering Scenesse to EPP patients. Circle the country and hit all the major cities every 60 days, and they'll treat enough patients to crowd out MT's trials.

There is literally NO REASON for a rollout to take 15+ months for such a small patient population.

If there are no sales by this year's AGM, I think it would be more than appropriate to introduce and pass a resolution revoking Wolgen's performance rights. This is embarrassing.
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Johnny H
Posted on: Mar 6 2020, 09:06 AM


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You had to cancel your vacation plans?
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Johnny H
Posted on: Mar 5 2020, 07:03 AM


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Same odds I gave Verharven.


Prove me wrong, Clinuvel. Prove me wrong.
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Johnny H
Posted on: Mar 5 2020, 07:02 AM


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It's not true.

I'll give you 1000-1 odds.
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Johnny H
Posted on: Mar 5 2020, 04:39 AM


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It looks like the MT trial is going to be delayed again. They initially had January 2020 as their primary completion date. They updated the status at the end of January, and now the primary completion date is March 2020. However, the status shows that they are still recruiting participants for the trial, so a March 2020 primary completion date is unlikely, and they'll probably delay the primary completion date again at the end of this month.

If anyone is interested in participating, it's in Miami, Florida, and they're recruiting healthy volunteers (not patients with EPP). I'd do the study if it was closer to me; there's probably a ton of valuable information to be had.
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Johnny H
Posted on: Mar 5 2020, 02:49 AM


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The aforementioned American Academy of Dermatology annual meeting is March 20th-24th, 2020.
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Johnny H
Posted on: Mar 5 2020, 02:47 AM


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A competent pharma company can commercialize a drug less than a year after the end of Phase III. And by commercialize, I mean actual sales; not just approval.

Source: another biotech company I'm heavily invested in.
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Johnny H
Posted on: Mar 4 2020, 09:13 AM


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That's the real estate agent's house. Er... I beg your pardon... Clinuvel's Director of US Regulatory Affairs.
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Johnny H
Posted on: Mar 4 2020, 06:45 AM


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On the APF website, the zip code listed for the only porphyria physician in Los Angeles is 90095, which is exclusively the UCLA campus.
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Johnny H
Posted on: Mar 4 2020, 05:18 AM


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One lesson from this is that Clinuvel staff are almost certainly reading our posts every day. If you have suggestions, let them fly.


I have one: since the website is "live", remove the EPP Centers page until it's ready. Right now, live, the map is directing patients to Los Angeles City Hall, and I don't think the other locations are real either.

Patients are already upset at lack of information; misinformation is a far worse offense.
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Johnny H
Posted on: Mar 3 2020, 01:15 PM


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No INDs have been filed with the FDA for either of the new molecules. They cannot be used in humans yet.
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Johnny H
Posted on: Mar 3 2020, 07:59 AM


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Nah, it's definitely Clinuvel.
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Johnny H
Posted on: Mar 3 2020, 07:10 AM


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5 months after approval, and they almost have a website!
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Johnny H
Posted on: Mar 3 2020, 04:37 AM


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A lot of media sources are citing corporate travel bans as evidence of how bad it's getting. The only reason companies are doing this is for liability protection. It has nothing to do with transmission risk.

Either people are going to get the coronavirus or they aren't. Companies don't want their employees to be able to claim that their illness was directly caused by business travel. It would expose them to a massive flood of workers comp claims, and yes, even some wrongful death lawsuits. If I were in risk management, I'd ban corporate travel too.


To keep this post on topic, CLVLY up 16% today.


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Johnny H
Posted on: Mar 1 2020, 05:36 AM


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You're confusing FDA regulations with SEC regulations. The FDA doesn't publicly acknowledge very much at all. They'll publicly disclose that they've approved a drug, or that they've recalled a drug from the market, and that's pretty much it.

The SEC reporting requirements are the issue here. And to reiterate, the SEC has access to all privileged communications between the FDA and a sponsor company.

If a major regulatory action occurs, an SEC reporting company HAS to disclose it. It's the law.

Secondly, all SEC filings MUST be truthful. It's a crime to knowingly file false statements. Lying about material information is securities fraud. Full stop.

Wolgen hasn't just lied about the RTF. There are at least 4 public statements that he's lodged with the ASX that are provably false. And, for reasons that defy logic and common sense, he released another public statement that seems to be bragging about sharing privileged inside information with preferred shareholders and select potential investors.

And let me be clear: getting listed on NASDAQ is ridiculously easy. It's a matter of paperwork and fees. The one and only thing that's stopping Clinuvel from doing so is the reporting obligations that come with the listing.

US securities laws are designed to prevent people like Wolgen from doing exactly what he has done.

When they say that they are looking for shareholders who "share our vision for the company", what they really mean is that they want investors who will stay silent in the face of questionable conduct, illegal activities, and rank incompetence.

If you ever find yourself wondering where their extreme disdain for retail shareholders comes from, it's this right here. We dare ask them to keep us informed and tell us the truth, and they're offended by the notion that they should have to meet their basic obligations as a public company. Basic, civil questions from shareholders result in immediate excommunication.

The first step to a NASDAQ listing is to upgrade from an ADR Level I to an ADR Level 2. Clinuvel hasn't even done that, and they won't going forward. Why? ADR 2s are SEC reporting.

Additionally, Wolgen has just disclosed that their first expected commercial sales will be at the end of 2020. So, best case scenario is commencing sales FIFTEEN MONTHS after approval, which by any measure is absolutely unacceptable. Do you think Wolgen has any intention of telling the truth about how and why this happened going forward?

So yeah... I'm gonna stick with my original point: there will not be a NASDAQ listing while Wolgen is CEO, and it's exactly for the reasons I said.
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Johnny H
Posted on: Feb 29 2020, 02:22 PM


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Yes, a NASDAQ listing would improve lots of things. Unfortunately, Clinuvel is not a good candidate for becoming an SEC reporting company, as I assume that Wolgen would like to stay out of jail.

I assume that during the course of Darren Keamy's research into listing on a US market, they discovered that there is an SEC-FDA liaison, and the two agencies freely share data. If you lie about what the FDA told you privately, you will get caught.

We will never have a US listing as long as Wolgen is CEO.
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Johnny H
Posted on: Feb 28 2020, 06:55 AM


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The issue with the EMA was strictly about how Clinuvel described their treatment for EPP on their official webpage.

"On a few occasions we had been asked or encouraged to modify the language on CLINUVEL’s website and remove what was perceived to be inappropriate definition of the lead treatment."

This is not uncommon for the official website of an approved medication. The sponsor and the regulatory agency agree on predefined language describing the treatment, and it's binding. Clinuvel is only allowed to claim what the regulator agrees the data has shown during the application review.

For example, if Clinuvel claimed on its website that "Scenesse eliminates pain associated with light exposure in EPP patients", the EMA might make them change it to "Scenesse may help reduce pain associated with light exposure in EPP patients".

This sort of thing is so common that in any other context, it would be unusual to even think it worth mentioning in a newsletter. But, we're talking about Wolgen in this particular case, and it's pretty obvious what he's trying to do.

Wolgen would have you believe that the EMA is silencing his ability to discuss Clinuvel's drug development pipeline. I assure you that this is not the case.

Unfortunately, this wasn't even the most misleading thing in the most recent newsletter.
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Johnny H
Posted on: Feb 27 2020, 01:52 PM


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The stock price is in free fall, and they release this pile of excrement in response? It's the most pathetic attempt at damage control I've ever seen, and of course it's going to make things worse. They keep hammering home the point that they have no idea what they're doing. But that's not what I'm mad about.

At this point, it's immoral to allow Wolgen to have control of the destiny of this molecule. He's not up to the task, and he's proven it time and time again..

It's time for him to take his millions and disappear. Countless patients are desperately waiting for treatment for a multitude of diseases and conditions, and they're not going to get it as long as Wolgen has control.

It's. Time. For. Wolgen. To. Go.

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Johnny H
Posted on: Feb 27 2020, 01:43 PM


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It's all a journey! They're going to figure it all out along the way!
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Johnny H
Posted on: Feb 27 2020, 01:20 PM


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I can't believe that they took this on a roadshow. Literally can't believe it.

What in the hell is wrong with these people?!?


I didn't think I could be further disappointed in management. I thought we had hit rock bottom. I was wrong.
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Johnny H
Posted on: Feb 27 2020, 08:38 AM


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It's still better than the US operations.

The "US Director of Clinical Compliance"? Still working as a realtor: https://skyboxrealty.com/portfolio/linda-teng-2/


Shouldn't her job at Clinuvel be.... you know.... full time?
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Johnny H
Posted on: Feb 25 2020, 12:59 PM


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Colossal screw up. Does not inspire confidence.
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Johnny H
Posted on: Feb 15 2020, 11:26 AM


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Roughly translated, the item on the agenda is:

"10. Decision on eligibility for medical-economic assessment: Product SCENESSE (company Clinuvel LTD)"
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Johnny H
Posted on: Feb 13 2020, 10:06 AM


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Wild guess:

I think they're going to ask the FDA to waive implants on placebo patients subsequent to the initial implant if the patient requests it. It's unethical to ask a patient to undergo a (very minor) surgical procedure if both the doctor and patient are aware that it's unnecessary.

The vitiligo indication is for Scenesse + UVB therapy, so the control could be UVB therapy alone. There's no reason for placebo patients to discontinue the UVB portion of the trial; it's free treatment.

Since the trial is functionally unblinded after about 10 days, the FDA may even allow Clinuvel to waive placebo implants altogether. This is something they'll have to come to an agreement on in the upcoming meeting.


The other thing they'll need to seek clarification on is trials across ethnic populations and bridging study requirements. Should they design the trial exclusively for darker skinned patients where they'll get a better p number, or should they design a trial for all skin types and get a lower p number but a much higher patient population upon approval?
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Johnny H
Posted on: Feb 12 2020, 02:43 PM


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EU regulations only require a QP for batch release.

Scenesse implants have always been manufactured in the US. The finished product is packaged and labeled for distribution in the EU by a contract QP, Catalent Solutions (previously in the UK, but since Brexit, in Ireland). It's also possible that terminal sterilization occurs in a European facility, but Clinuvel has never publicly disclosed if this is the case.

Long story short: Scenesse is produced in the US and packaged in Europe to comply with EU regulations.
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Johnny H
Posted on: Feb 12 2020, 08:09 AM


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There won't be a generic version of Scenesse for decades, if ever.

There is one place on the planet capable of making it (Evonik Birmingham Laboratories, formerly Surmodics), with whom Clinuvel has an exclusive licensing and royalty agreement. In that facility, there is only one machine capable of producing Scenesse, and it's proprietary.

Competitors have neither the knowledge nor the equipment to manufacture a generic version of Scenesse, and even if they did, Clinuvel would never provide the reference samples required for a bioequivalency trial. Controlled distribution FTW.


Of all of the issues facing the company, generic competition is not one of them. Not even a little bit.
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Johnny H
Posted on: Feb 11 2020, 02:55 AM


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"could serve as an important surrogate parameter"

You're definitely on to something there.

Normally, Clinuvel would request a type B (EOP) meeting at this phase of development. Type B EOP meetings are:
"End-of-phase 2 or pre-phase 3 meetings (21 CFR 312.47)"

However, Wolgen specifically stated that Clinuvel is requesting a type C meeting with the FDA. Type C meetings are:
"any meeting other than a Type A, Type B, or Type B (EOP) meeting regarding the development and review of a product, including meetings to facilitate early consultations on the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in the proposed context of use."

We already know what the endpoint is for vitiligo: VASI score. It's very easy to measure changes in total body pigmentation. So... what else are they trying to measure?


[FDA guidance on applicant meetings attached]
 
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Johnny H
Posted on: Feb 10 2020, 09:59 AM


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In re: the type C meeting, it's absolutely the right thing to do. Once the FDA and Clinuvel agree on trial design and endpoints, it's binding on the FDA. If the data shows that Scenesse is effective for treating vitiligo, the FDA has to accept the data.

This is something Clinuvel should have done for EPP, but for whatever reason, didn't.

The good news: sNDAs are much faster. Clinuvel can reuse 4 of the 5 modules that they used in the NDA for EPP. No risk of a CRL for CMC issues or safety issues.

The bad news (or not so good news, if you prefer): The vitiligo trials, if similar to previous ones, are quite lengthy. 180 days of active patient participation at a bare minimum. If Clinuvel is setting up for a phase IIb trial, it means they later have to do a phase III, which will be just as lengthy if not longer. Best case scenario is Scenesse approval for vitiligo in 2023. I would be shocked and very pleased if Clinuvel is able to deliver on the best case scenario.

Vitiligo approval is the catalyst for making the company "orders of magnitude larger", so I'm glad we have some concrete evidence that they are now taking steps to achieve this.
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Johnny H
Posted on: Feb 7 2020, 08:53 AM


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That's pretty much it, except for that one hand doesn't know what the other is doing (allegedly). It's all driven by algorithmic trading, and in theory and in law, different institutions shouldn't be colluding, but competing instead.

Another way to think about it: the shares locked up in the funds and shorted are now part of the free float, where they weren't before. It's no different than in Clinuvel announcing a capital raise and minting a million new shares.

Of course, it devalues existing shares, but it's done all at once (in this case last June), and is not an ongoing process.

I do think that there are investors with net short positions (see: before ASX 200 inclusion), but these institutions aren't necessarily taking part. If so, that means there is a hard cap as to how many shares they will short. I'd like to think that we're pretty close to the limit, but I could be wrong.

Regardless of whether you think the chicken or the egg came first, my original point stands: the decline in share price is due to market sentiment towards Clinuvel's business execution strategy (or lack thereof). We are now passing 1/3rd of one year since FDA approval, and.... crickets. Does Clinuvel even have an office in the US yet?
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Johnny H
Posted on: Feb 7 2020, 05:05 AM


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That is 100% correct, except in cases of market making. Market makers operate on both sides of the transaction. The shorters in question are continuously offering to both sell shares (opening a short position) and buy shares (closing a short position) at the same time. The market dictates the net effects, and the market makers are a neutral party.

CUV is no longer a thinly traded stock, largely due to this market making. Unfortunately, this increased liquidity makes CUV an increasingly attractive target for algorithmic trading, which is not a good thing when the stock has poor fundamentals.





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Johnny H
Posted on: Feb 6 2020, 05:00 PM


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CUV weight stays the same. Index funds short their own shares to engage in market making activities.

If a retail investor takes a short position, it costs him money in the form of interest paid to borrow the shares. Index funds loan shares to themselves, so it costs them nothing to short.

When these shorted shares are used for market making, they are on both sides of the transaction. When a market maker buys shares, they're closing a short position. When a market maker sells shares, they're opening a short position. Supply and demand dictates both the share price and outstanding shorts. The same price discovery mechanism driving the increase or decrease in share price also drives the increase or decrease in shorts.

Price and shorts don't track 1 to 1, obviously, as there are legitimate buyers and sellers, but they do trend together long term. In the case of Clinuvel, I would guess that it tracks pretty closely, as a lot of the volume seems to be churning and day trading.

When new investors start buying up Clinuvel, we'll know about it. It should be pretty obvious.

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Johnny H
Posted on: Feb 6 2020, 12:43 PM


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The index funds absolutely do. They're forced to buy at an inflated price because of inclusion announcement frontrunning, so they immediately turn around and short it. Because the S&P indexes are specifically designed to be extremely low turnover, the index funds will never have to buy back the shares that they shorted. This is how index funds make money on low dividend stocks. They can't sell stocks for capital gains as long as they're part of the index, and on the other hand, they do not have to buy back shorted stocks as long as they're part of the index.

Additionally, many of the theories posited here lately have causality exactly backwards. The share price isn't declining because of shorts. Instead, the shorts are increasing because of declining share price. This is typical of market making using shorted shares. How do we know that market making is being done with shorted shares? Because daily volume increased after ASX 200 inclusion.

How is it possible that average daily volume almost doubles when more than a million shares are suddenly locked away in index funds forever? Shouldn't taking a million shares off of the market make volume go down? The answer: equity shorts. The index funds are engaging in market making with shorted shares.

Share price goes up? You'll see a net decrease in shorts as the market makers buy more shares than they sold short that day. Share price goes down? You'll see a net increase in shorts as market makers sell more shorted shares than they buy back that day.

The massive increase in average daily volume we've seen in the last few months? It's all the same shares changing hands over and over again.


It's easy to blame the shorts, but also intellectually lazy. The exact same thing happened after EU approval (without shorting), and there's no reason to believe that it won't happen again.

The sole factor driving down the share price is the same as it has always been: poor execution.

Clinuvel needs to publicly state their timelines for rollout, and then meet or exceed their publicly stated goals. Until they do, nothing is going to change. The share price will continue languish like it did 5 years ago.

Do I except the share price to be ridiculously high in a few years? Yep. Do I have better things to do with my money right now? Also yep.
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Johnny H
Posted on: Feb 6 2020, 11:39 AM


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The warrants are not backed by shares; the settlement is cash at the time of exercise.

Interesting that the warrants were at an all-time high the first week they were issued last November, and have been on the decline ever since.

Also worth noting that Citi only issued mini longs, which is effectively a short position.
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Johnny H
Posted on: Feb 4 2020, 11:01 PM


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To my knowledge, Clinuvel has not filed an IND (pre phase I) for either of their new molecules. They would need to do it before any testing in humans.
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Johnny H
Posted on: Feb 3 2020, 10:26 AM


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QUOTE
"We rejoice each step towards our objectives,” CLINUVEL’s Regulatory Affairs Manager, Dr Monique Baldwin said


Perhaps she should be under consideration for full time employment with Clinuvel. It kind of seems like an important position to me.
https://www.linkedin.com.au/in/monique-baldwin-572b6179/

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Johnny H
Posted on: Jan 31 2020, 10:23 AM


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IIRC, there was one patient who ceased treatment and she specifically cited pregnancy as the reason for doing so. Time to conceive + pregnancy + breastfeeding.... she'll be back in a few years.

Also... there are (at least) 2 patients who have died since beginning treatment (for reasons unrelated to EPP). They would also be included in the patient continuation rate metric. You can't continue treatment if you're dead.

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Johnny H
Posted on: Jan 31 2020, 09:59 AM


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"Administration and corporate costs increased from the prior quarter to support a number of activities including renewing key annual insurances and supporting various investor and public relations activities."


I'm not sure why insurance premiums would increase significantly if they're renewing the same policies.

As for "various investor and public relations activities".... money well spent, amirite?
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Johnny H
Posted on: Jan 30 2020, 04:46 AM


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I ran a self-trial in 2007. Memorial Day weekend in Kauai (tropical sun almost directly overhead). I'm a Fitz 2 (family is from Norway). I hiked the Kalalau Trail, which I would highly recommend; one of the most beautiful places on earth.

We left at 6am. I figured... I'll wait until 10am, and then put on sunscreen, that way, I'll only have to apply it once. We were making really good time, and for whatever reason, I forgot to put on sunscreen. 12+ hours in the tropical sun, no shirt or hat.

I wasn't sunburned in the slightest. If I hadn't been running a trial of MT1 on myself, the simple mistake of forgetting to put on sunscreen would have landed me in the hospital for several days with 3rd degree burns.

That's when I decided to invest a big chunk of change.

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Johnny H
Posted on: Jan 26 2020, 10:58 AM


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P value for a reduction in total body VASI score was <.001.

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Johnny H
Posted on: Jan 22 2020, 04:54 AM


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Index inclusion (twice) and the associated front-running preceding it.
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Johnny H
Posted on: Jan 22 2020, 04:53 AM


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It's spam. Poorly written spam. He's done it on a few others stocks at Sharecafe as well.

That such drivel gets "thanks" in this forum is an indication of how starved we are for information on Clinuvel.
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Johnny H
Posted on: Jan 21 2020, 06:47 AM


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I'm told that having no debt is the greatest achievement in the history of mankind.
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Johnny H
Posted on: Jan 21 2020, 01:38 AM


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In some of the interviews I've seen with US EPP patients, some of them are so sensitive to light that they'll have a painful reaction indoors to the wrong kind of lightbulb. Their sensitivity isn't to seasonally & latitude dependent UV light, It's to nearly ubiquitous blue light (450–495 nm). Eumelanin happens to filter both.

One patient, who spoke about her EPP at Yale Medical Center in honor of Rare Disease Day 2018, had to conduct the presentation with the lights turned off in the classroom because she could feel a reaction starting. The room had no windows. This same patient was able to go to the beach on a sunny day while on Scenesse.

While there are a few milder cases of EPP where the patients might limit their treatment to 4x a year when they're most likely to be outdoors, there are many patients who, regardless of the climate where they live, will absolutely will need treatment 6x a year just to be able to take the sheets down from their bedroom windows.

I don't recall the exact reason that the EMA gave for recommending 4 implants per year, but it's absolute rubbish. They might have claimed that there was a valid medical basis for their decision, but there isn't. It's quite obviously a cost-saving measure. The FDA doesn't consider cost of treatment in their decision making process, and their assessment contains no such restrictions.
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Johnny H
Posted on: Jan 20 2020, 09:51 AM


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US patients theoretically have access to 6 implants per year. 6 x 60 days = 360 days, or pretty much the entire year.

Every day that Scenesse remains unavailable is another day that Clinuvel loses money.

If Clinuvel had been ready to distribute at approval, most US patients would be halfway through their 2nd implant by now. That's quite a missed opportunity, both financially and for the patients who have been patiently waiting in the dark.
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Johnny H
Posted on: Jan 19 2020, 04:38 PM


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Implications of the bill are zero.

The State of Georgia, for reasons that defy common sense, defines a "dangerous drug" as any drug that requires a prescription.

The list of drugs under "Section 2." are drugs that were approved by the FDA in 2019, so now they're "dangerous drugs".

It's dumb, and I have no idea why they do it.





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Johnny H
Posted on: Jan 19 2020, 06:15 AM


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According to the action package that was posted on the FDA website until Clinuvel had it removed, Scenesse will not be on the list of controlled substances... i.e. it will be unscheduled.

Scheduled drugs fall into 5 categories: narcotics, depressants, stimulants, hallucinogens, and anabolic steroids.

Scenesse is obviously not 4 of those, so the only thing they were required to test for was stimulant properties. The 2 tests that they performed for stimulant abuse potential (self-administration in trained rats and human subjects with a prior history of stimulant abuse) showed that there was zero potential for abuse as a stimulant. Statistically, Scenesse had the same abuse potential as the placebo. The FDA accepted this data as part of the NDA and did not recommend that the DEA consider it for scheduling.

This will make it much easier for Clinuvel to self-distribute, as the licensing requirements for manufacturing and distributing controlled substances is quite burdensome.

An added benefit is that doctors cannot be criminally charged under the Controlled Substances Act for off-label prescriptions. They can write as many prescriptions as they want, for any reason, without fear of prosecution or loss of medical license.
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Johnny H
Posted on: Jan 17 2020, 10:03 AM


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Clinuvel will need to conduct a bridging study before they can file a new drug application in Japan. To my knowledge, they have not done so.
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Johnny H
Posted on: Jan 16 2020, 11:51 AM


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"Every shareholder has the free will to invest in CLINUVEL and we aim to attract like-minded and compatible long- term shareholders; we also reserve the right to not respond to those who ignore their obligations and lack the graciousness to communicate in a civil fashion and cannot share our strategy. Our philosophy is to advise the market, and thus all small and large shareholders, of developments and progress of the Company on a timely basis."

Stan McLiesh, Chair Letter, November 20th, 2019

"The period from the FDA’s milestone approval on 8 October 2019 through to the AGM on 20 November was a particularly intensive period for investor relations. Key CLINUVEL personnel across a range of geographies were involved in many meetings with existing and potential shareholders and other stakeholders to communicate the developments in the business."

Phillipe Wolgen, Newsletter regarding the same time period.



I'm not sure which one I want to be true, but it can't be both.
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Johnny H
Posted on: Jan 15 2020, 05:54 AM


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From Pharmacy Benefits Manager Prime Therapeutics:

QUOTE
ScenesseTM (afamelanotide): The FDA approved Clinuvel Pharmaceuticals’ Scenesse, which is the first drug to increase pain‐free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria. Scenesse is administered via a dissolvable implant inserted subcutaneously every two months. According to a Clinuvel spokesperson, “We refer pricing to our approach to pricing in Europe.” Scenesse is priced at approximately $15,695.19 per injectable implant, or $62,780.75 per patient based on four injectable implants per annum (excluding local taxes). Clinuvel will distribute the drug directly to hospitals within the year.4


More evidence that the alleged 2H21rollout was a typo.
Attached File(s)
Attached File  Oct_19_Specialty_Pipeline_Update_NL_.pdf ( 206.86K ) Number of downloads: 146

 
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Johnny H
Posted on: Jan 15 2020, 05:34 AM


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I'm gonna keep my money in APLT until I see some evidence of adult supervision in this company.
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Johnny H
Posted on: Jan 15 2020, 04:56 AM


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Each Blue Cross Blue Shield company selects their own PBM (Pharmacy Benefits Manager). Prescription drug coverage is likely to be the same for BCBS plans using the same PBM. 16 or more of the 36 companies operating under the BCBS brand use Prime Therapeutics as their PBM (Prime is actually owned by a consortium of 16 BCBS companies).

BCBSWNY apparently does not use Prime. From the their website: "We partner with the largest pharmacy benefit manager (PBM) in the country to provide a comprehensive benefits package". While they don't explicitly state it, they are referring to Express Scripts, which is the largest PBM in the country,

The good news is that Express Scripts manages prescription drug plans for many other insurance companies. The largest PBM in the country has given the green light in at least one case that we know about. They're likely to give the green light every additional time that the question of Scenesse coverage is raised.

The bad news is that some BCBS plans not using Express Scripts might not yet cover Scenesse. That's not to say that they won't cover it; just that they haven't yet released a policy saying they will. However, after a brief search, it appears that many PBMs will not explicitly publish formulary coverage for rare diseases. For many PA (prior authorization) drugs, they require a phone call or a written request to check coverage.

For example, OptimumRX (the PBM for United Health) has information about Scenesse on their website, but does not indicate under what circumstances they will provide coverage (see attached).


Long story short, I think it's likely that all private insurance in the US will cover Scenesse, but it's going to take time and paperwork to get that coverage. Additionally, we're not likely to find out about it in advance, and won't know much of anything until after it happens.

That one private insurance company has already publicly stated that their policy is to provide coverage for Scenesse is great news, and they probably reached that policy at the request of an EPP patient covered by their insurance plan.

I hope to hear about more patient successes soon.
Attached File(s)
Attached File  drugapprovals_scenesse_2019_1010.pdf ( 39.21K ) Number of downloads: 52

 
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Johnny H
Posted on: Jan 10 2020, 08:49 AM


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Clinuvel hasn't made so much as a peep about US sales or rollout.

It's been 94 days since the FDA approved Scenesse in the United States.

94 days.

Unacceptable by any standard.
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Johnny H
Posted on: Dec 23 2019, 09:25 AM


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Clock hasn't started; TGA has to validate and formally accept the submission.


I would have preferred that they announce only when it is accepted by the TGA to avoid a repeat of what happened with the FDA. Still though, this is surprising and unexpected news. Here's hoping.


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Johnny H
Posted on: Dec 18 2019, 10:09 AM


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Everything in the APF list is a represented by a dot on the map. I don't think they've set the others up yet, as they're still identifying doctors and clinic locations.

I'm looking forward to hearing about a new location in Los Angeles or San Diego. There are 24 million people in Southern California, 2 million in the Las Vegas valley, and 5 million in the Phoenix metropolitan area. A single location could serve more than 10% of the US population.
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Johnny H
Posted on: Dec 17 2019, 04:34 AM


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EPP specialty centers as of today.

New locations that did not participate in the clinical trials: Miami Fl, Seattle WA, and Winston-Salem NC.

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Johnny H
Posted on: Dec 14 2019, 04:18 AM


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Exactly. There's a reasonable middle ground.

They don't need to license out or give up control. But a $1-2 million consult with Icon PLC to jumpstart distribution would be nice.


Rolling out 6 months earlier would mean an additional $10-$15 million in revenue that would otherwise be lost, and also helps protect against competition. Totally worth it.
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Johnny H
Posted on: Dec 14 2019, 03:37 AM


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The impression I got is that Bull was instructed to conduct IR in this fashion. He was open and responsive at first, and then something changed. He probably received the same instructions as Keamy: avoid replying to investors unless you are legally obligated to do so.

If Bull was hoping to transition from a career in banking to a career in investor relations, he picked the wrong stepping stone.

Having a bull isn't very useful if he's castrated.
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Johnny H
Posted on: Dec 13 2019, 02:02 PM


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Wolgen: Distributing directly to hospitals "disintermediates" third parties (insurance companies and PBMs).
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Johnny H
Posted on: Dec 13 2019, 09:07 AM


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UK election results are great news for Clinuvel and drug reimbursement.
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Johnny H
Posted on: Dec 12 2019, 02:44 PM


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It's a rumor that's been floating around for years.

Smaller firms might have a system where the sell order flags the shares as non borrowable, but in a larger firm, the shares are pooled. If it's in their inventory, they'll loan it out. Your shares are in their inventory until they're sold and cleared.

The only way to prevent your shares from being loaned out are

-holding them in a cash account instead of a margin account

or

-requesting a certificate so that the stock is registered directly in your name (most brokerages actually won't let you do this anymore)

There are very few equity shorts for CLVLY. It's classified as "hard to borrow", which means it's really expensive to borrow (think credit card interest rates for someone with poor credit). Most of the shorts are naked shorts, which are done by market makers and are usually covered within 15 days.

You can see equity vs naked here:
https://otcshortreport.com/company/CLVLY


I'd avoid a GTC order unless you REALLY want to sell at $50. If a takeover offer comes in at $75, you're out 5 million bucks.
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Johnny H
Posted on: Dec 10 2019, 06:56 AM


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Receipts from customers for FY 2019 was $32.2 million, and that's with EU market penetration on the lower end.

If I had to guess, those numbers are for EU only and projected based on intermediate market penetration. I would expect a complete EU rollout to be somewhat higher.

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Johnny H
Posted on: Dec 6 2019, 11:41 AM


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McLiesh.


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Johnny H
Posted on: Dec 6 2019, 11:26 AM


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It's a definite possibility, but I certainly hope not. I would be very disappointed to find out that Clinuvel is wasting time and manpower on something like this when there are more important matters to attend to.
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Johnny H
Posted on: Dec 6 2019, 09:54 AM


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It appears that the entire action package for Scenesse has been deleted from the Drugs@FDA website. As this is highly unusual, I've reached out to the FDA to find out why, and will report back.

In the meantime, I have copies of each of the documents if anyone is interested.
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Johnny H
Posted on: Dec 6 2019, 01:36 AM


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In my humble opinion, they have no other option than to license out in Japan. Is Wolgen going to learn Japanese and argue in front of their medicines agency? Seek out MT's biggest competitor and license with them to get a leg up on the competition. There are a lot of porphyria patients in Japan, and I'd like Clinuvel to at least have a fighting chance.
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Johnny H
Posted on: Dec 4 2019, 12:51 PM


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Of the photos I've seen of 3 people in the active arm of the trial, none were even slightly "tan", and 2 had mild sunburns.

If you compare it to photos of people in the active arm of the Scenesse trial, it's night and day.
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Johnny H
Posted on: Dec 4 2019, 12:48 PM


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Sorry, forgot to include the screenshot. From the February 11th, 2004 announcement.



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Johnny H
Posted on: Dec 4 2019, 12:30 PM


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If you think of the peptide/receptor action as a lock and key model, there are 2 things that matter for receptor activity: how well the key fits into the lock, and how long the key stays in the lock. The duration is determined by binding affinity, and the fit is determined by ligand conformity. If either one of these is deficient enough in the molecule to prevent full activation of the receptor, the molecule is only a partial agonist.

If I had to guess, MT has a conformity problem. If it was a binding affinity problem, they could increase the frequency and dosage to correct the problem. They're already at dose every day for 16 weeks. There's probably no dose for which they'll get full receptor activity.

Meanwhile, when Clinuvel first tested the implant, they found that they had to lower the dosage of the initial formulation. They got full receptor activity at a much lower dose than they had initially thought. I'm not sure about the conformity (I think it's roughly the same as MSH), but afamelanotide has an extremely high binding affinity. Not only does this result in prolonged activity in the receptor, but it also (theoretically) prevents antagonists from binding.

I'm not sure how important the latter is, but there is some preliminary research that shows that redheads and light skinned people have an excess of ASPs (agouti signaling proteins), which might act as an MC1R antagonist (which turns the receptor off). If afamelanotide is bound to the receptor for a prolonged period of time, it blocks ASPs from binding.
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Johnny H
Posted on: Dec 4 2019, 09:35 AM


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Short term: maybe
Long term: probably not

MT's drug appears to be effective in EPP patients, but not very effective in the way of photoprotection, and by extension, DNA repair. As I've speculated before, it appears to only be a partial MC1R agonist which produces just enough melanin to block inflammatory light (blue spectrum), but not enough to prevent sunburns. (I'm a Fitz II, which means that endogenous MSH is already a partial agonist in my body due to MC1R receptor mutations. I have literally no use for another partial agonist. It's worthless to me and millions like me... if my speculation is correct).

If approved for EPP, MT would cut into Clinuvel's revenue stream and create difficulties in funding new indications and products, but MT isn't likely to be a threat to the new indications themselves in the form of competition.


MT may or may not be approved. Your guess is as good as mine.

But, and I feel very strongly about this, Clinuvel should proceed with a business strategy under the presumption that MT will be approved unless they learn otherwise.

I would love an update from management about their plans for a quick and efficient rollout in the US market, as it's the most pressing issue facing the company and its shareholders right now. They haven't mentioned it once, and it's very frustrating. IMO, this, and not shorting, is the primary driver of the declining share price.
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Johnny H
Posted on: Dec 4 2019, 05:48 AM


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Interesting. I did not know about this:

QUOTE
Finally, using a light-sensing wristwatch, it could be shown how light exposure was nearly normalized in the Dutch patient cohort as compared with healthy controls [33]. In the future, other devices under development could provide us with a better understanding of the interaction between light and patients with EPP [34].
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Johnny H
Posted on: Dec 4 2019, 04:12 AM


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It's a moot point, since afamelanotide, much like insulin, is not orally active. No technology currently exists that would make afamelanotide orally active. In theory, making an orally active version would involve designing an entirely new molecule that includes a cyclic hexapeptide and protective groups, which would put drug development back in the pre-ind phase.

The very thing that makes afamelanotide so safe is also what makes it hard to deliver, and necessitates a depot formulation to achieve efficacy. In the stomach, it is metabolized into..... food. In the bloodstream, it is metabolized into.... food. The metabolic pathways of afamelanotide (hydrolysis and proteolytic cleavage) are so safe that the FDA didn't even require a metabolic profile to be included in the NDA. Because, again... it turns into food. Unlike MT-7117, metabolism of afamelanotide doesn't even involve the liver, which is an obvious plus for EPP.

MT-7117 has the convenience advantage, but Scenesse has the clear safety advantage.

We're going to have to wait and see what the PII results are. If there are any AEs related to liver function (and there might be), MT-7117 is dead in the water. Done. If not, we might have some serious competition. It could go either way based on their decision to do a liver toxicity trial after the Phase II. It raises the questions of both toxic metabolites and serious D-D interactions. Either would be a fatal blow.
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Johnny H
Posted on: Dec 3 2019, 06:04 AM


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Well, they do have a real estate agent and her cell phone. Is that enough?
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Johnny H
Posted on: Dec 3 2019, 02:31 AM


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Presented without comment:

QUOTE
FAQ# 12 - What does OOPD consider a “major contribution to patient care?”
Major contribution to patient care (MC-to-PC) is a narrow category and is not intended to open the flood gates to orphan exclusive approval for every drug in which a minor convenience over and above that attributed to an already approved drug can be demonstrated. For example, FDA has identified as providing a MC-to-PC the development of an oral dosage form where the previously approved versions of the same drug for the same use are only available in a parenteral form. However, each measure of MC-to-PC stands on its own and it could be possible that an oral dosage form is not superior to a parenteral form.

The following factors, when applicable to severe or life-threatening diseases, may in appropriate cases be taken into consideration when determining whether a drug makes a MC-to-PC: convenient treatment location; duration of treatment; patient comfort; reduced treatment burden; advances in ease and comfort of drug administration; longer periods between doses; and potential for self-administration.

Factors that FDA cannot consider when determining whether a drug makes a MC-to-PC include: cost of therapy (FDA has no authority on drug pricing or any authority to consider it in drug approval), and compliance to therapy (significantly improved compliance should be reflected by a measure of greater safety or efficacy).


The way to deal with this is obvious to me. Note the exclusion criteria for the MT-7117 trial:
QUOTE
Treatment with afamelanotide within 3 months before Randomization (Visit 2).


Start delivering Scenesse NOW! If insurance won't cover it, give it away, write off the cost, and negotiate later. If patients are taking Scenesse, which they know works, they aren't going to quit for 3 months so that they can end up in a clinical trial where they might get the placebo. Every US EPP patient needs to be on Scenesse yesterday.
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Johnny H
Posted on: Nov 30 2019, 02:45 AM


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Webpage not updated? You're probably right. It's not a phase III. Conceded.

My original point still stands. The reason that there are fewer restrictions on the most recent trial is because they are testing to see if it is hepatotoxic. It is not a test for efficacy. They want to see, in a single dose, regardless of the oral bioavailability of the drug, whether or not it has negative effects on the liver, and whether it can make existing liver problems worse.

You cannot infer the outcome of a bioavailability trial based on the exclusion criteria of a hepatotoxicity trial. It doesn't matter when the drug is absorbed or where in the body it is metabolized in this trial.

The only thing you can conclude from the information available is that the bioavailability trial was completed.

Your statements:
"They completed their bioavailability study and had very good data by appearance."
and
"Obviously Tanabe's bioavailability trial was a success and there is no concern regarding MT-7117 and absorption. This is what the actual trial events indicate."

are not supported by the available facts. They have not released the trial data or the results.

Also, my statement that the discrepancy between the trial goals is "interesting".... is not misleading, even if I got the chronology wrong. They designed their Phase II to avoid high ph in the stomach, and less than a few months later, launched a bioavailability trial where one of the arms of the trial required a high stomach ph. That, to me, is very interesting, and I'm going to keep an eye on it and try to make sense of it as more information becomes available.

I've moved on from the whole MT-7117 issue. But, if you're going to keep beating a dead horse, you should at least be asking the right questions:
Why did MT launch a bioavailability study after they had already started their Phase II trials?
and
Why did they feel the need to launch a hepatotoxicity trial after their Phase II was already completed?

The answers to these questions should be.... interesting.

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Johnny H
Posted on: Nov 30 2019, 01:04 AM


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You obviously didn't read the link. This is for PHASE THREE: https://healthcare.utah.edu/clinicaltrials/...p?id=FP00012322


Further, there's no way to determine if the bioavailability trial was a success or not because YOU HAVE NO IDEA WHAT THEY WERE TESTING FOR.



Good day, sir. (read this in bold too)
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Johnny H
Posted on: Nov 30 2019, 12:19 AM


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He's doing his own personal clinical trial of Adderall. Wheels came off the wagon on day 13.
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Johnny H
Posted on: Nov 29 2019, 11:57 AM


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Interesting. In the last trial, MT-7117 was co-administered with a PPI (proton pump inhibitor), which significantly raises the ph of the stomach. Now, they're trying to avoid raising the ph.
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Johnny H
Posted on: Nov 28 2019, 10:04 AM


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MT-7117 isn't an immunosuppressant.

Immunomodulators fall into 2 categories: immunosuppressants and immunostimulants. MT-7117 and Afamelanotide are the latter. Melanogenesis is an immunological response to UVB radiation damage. Both drugs increase this response.
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Johnny H
Posted on: Nov 26 2019, 03:29 AM


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"Unlimited validity" refers to how long the marketing authorization is valid for. The EMA initially grants marketing authorization for a period five years, after which it has to be renewed (this is true of standard and exceptional circumstances marketing authorizations, but not conditional approval, which is valid for one year). After the five year renewal, the market authorization is valid for an unlimited period of time.

Clinuvel will not have to submit an application for marketing authorization again, but the approval is still under exceptional circumstances, and is still subject to the annual review and post marketing requirements.

One of the post marketing requirements was for a period of six years, so they will have satisfied the requirement by next year.

According to the EMA website, applications approved under "exceptional circumstances" generally do not become a "standard" marketing authorization. This would instead be done under a "conditional approval", where the application is renewed every year until there is enough data to grant a standard authorization.

Perhaps one day Clinuvel will be the exception if they collect enough real world evidence for standard marketing authorization, but for now, their authorization remains under exceptional circumstances.


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Johnny H
Posted on: Nov 25 2019, 03:41 PM


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If you're going to link to an article as a gotcha, you should probably read past the headline.

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