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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: 113

 
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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: 31

 
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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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Johnny H
Posted on: Nov 25 2019, 11:26 AM


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Afamelanotide is a peptide, which is broken down in the stomach almost immediately by pepsin. It even counts towards your daily protein requirement.

The oral route is quite simply not possible with currently available technology. If it were, there would be oral insulin.


As far as being slow, Clinuvel is the one who waited until the middle of last year to submit the application. The FDA can't start reviewing a drug before they've received an application. When the FDA did receive the NDA, they assigned it priority review, and allocated resources to potentially approve it a month early.

Clinuvel waited to submit their application, and when they did, it had several mistakes. The delays are on them.

Clinuvel has to do their part, otherwise, the Fast Track and Priority Review designations are worthless.
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Johnny H
Posted on: Nov 25 2019, 04:21 AM


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As far as EPP, MT-7117 does appear to be effective at treating it. This is the basis for one of my biggest criticisms of the company strategy. There is a very limited patient population, and if that population is being treated with Scenesse (which they would jump at the chance to do), they cannot participate in the Phase III MT-7117 trials. This is why I have suggested giving the treatment away at cost while negations with insurance companies are taking place. Patients who are willing to participate in clinical trials are also the patients who are most likely to seek treatment, so Clinuvel should make the treatment available now.

As far as other indications for MT-7117, I'm going to tread lightly here, as it would be highly inappropriate to violate anyone's personal privacy. That said, from what I've seen, MT-7117 only appears to be a partial MC1R agonist. Even in mid-to-late course treatment of the PII trial (near the end of the 16 weeks), you cannot visually tell that patients on the active arm (as opposed to the placebo arm) are taking a drug that supposedly darkens the skin. In fact, 2 of the caucasian EPP patients actually got mild sunburns while they were in the trial. I do not know if they were on the high or low dose arm of the trial, and they probably don't know either. So, MT-7117 appears to be effective enough in EPP that patients can stay outside until they get a sunburn. On the other hand, patients can get a sunburn, so the photoprotective effects of MT-7117 are questionable at best. If patients can get sunburned while on the drug, I also question its ability to repair DNA.

As far as Avita is concerned.... ReCell is a surgical procedure. In involves surgically removing your own skin from somewhere else on your body. Should Scenesse and ReCell be approved for vitiligo at the same time, Scenesse would be the first choice of treatment, and the resistant areas (usually hands and feet) would be a candidate for ReCell. Treating large areas of the body for vitiligo with Recell would involve removing large amounts of skin, which most doctors and patients would avoid if at all possible. In my estimation, ReCell will be the last line of defense when other treatment options have failed.

There are many factors that weigh heavily in Clinuvel's favor, and my confidence in the molecule is as high as it has ever been. Management? I think I've beaten that horse enough for now.
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Johnny H
Posted on: Nov 25 2019, 03:47 AM


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"It's patent is running out"

Which patent are you referring to? The 4,7 a-MSH patent from University of Arizona expired a long time ago.
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Johnny H
Posted on: Nov 24 2019, 01:32 PM


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The actual interest rate for the funding fee is posted each morning on the ASX, and it's an annual interest rate. Daily rate = (posted rate) / (365).

Citi (or other issuer) captures the funding fee by adding it on to the strike price each day that it's held overnight (so 3 days for minis held at market close on Friday).

When a stop loss is triggered, the mini goes into a trading halt, Citi closes their hedges on the underlying, and the stop loss amount is determined based on Citi's closeout costs. The mini re-enters temporary trading, and Citi gives you the rest of the trading day and the following trading day to sell it back to them at the stop loss amount. If you don't, they liquidate it for you and forward you the balance within 10 days. The interest (funding fee) has already been incorporated into the strike price over the period that you held the mini.

You are correct, you don't lose the entire value of your investment; you get to keep the equity below the stop loss amount.

If the stop loss is closer to the strike price, you lose more money. If the stop loss is closer to the underlying price, the risk of triggering a stop loss is higher. It's a balancing act.


Attached File(s)
Attached File  20191105_singlestock_MINIs.pdf ( 575.64K ) Number of downloads: 58

 
  Forum: By Share Code

Johnny H
Posted on: Nov 24 2019, 01:02 AM


Group: Member
Posts: 854

There's a catch: stop loss.

The higher the effective gearing, the closer you are to the stop loss. For a stock that seemingly goes down for no reason, that could be quite risky,
  Forum: By Share Code

Johnny H
Posted on: Nov 22 2019, 05:13 AM


Group: Member
Posts: 854

One of the reasons the meeting didn't go over well (in addition to the incentives) is that timelines for anything were conspicuously absent. The reason they didn't give a timeline is because they don't have one. They have no idea how long it's going to take to roll out sales or get a new indication approved.

Instead, they thought that a couple of hastily photoshopped slides would placate investors. It did not, and had the opposite effect. The misdirection and sleight of hand was obvious and insulting. I want a timeline and an explanation for the new product line, not a poorly photoshopped mock-up.

For future reference:
-prescription creams and lotions are packaged in sealed and sterilized aluminum tubes, not cosmetic jars or pump bottles.

-it is illegal to name a product "Scenesse lotion". You can't use the name of an approved medication in a product name unless it IS that product, and a lotion by definition can not be a 16mg implant.

-if you're trying to inspire confidence in your new product line, you should probably come up with the names earlier than the weekend before the presentation (see pic)

These kinds of mistakes are embarrassing and scare away institutional investors. Unfortunately, in spite of its values statement, Clinuvel has adopted a culture where pointing out mistakes is not tolerated. Criticism, no matter how constructive, is met with defensiveness and hostility.

A year ago, I was completely against the idea of a takeover. Now, I'm praying for it.
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Johnny H
Posted on: Nov 22 2019, 03:39 AM


Group: Member
Posts: 854

Will not apply to EPP patients, as the heme precursor accumulations causing the symptoms are completely different.
https://www.ncbi.nlm.nih.gov/books/NBK537178/

QUOTE
"For acute porphyrias, which primarily affect the nervous system, the cause of symptoms seems to be the increased production of neurotoxic precursors. With chronic porphyrias, which primarily have skin manifestations, the cause of symptoms seems to be the buildup of photosensitizing porphyrins in the skin."


However, there might be a lesson for Clinuvel here:
https://www.porphyria.com/ahp-resources

Alynlam's website for a drug that was approved YESTERDAY. They are offering free testing and counseling (read: diagnosing new patients).
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Johnny H
Posted on: Nov 21 2019, 06:46 AM


Group: Member
Posts: 854

The dilution hasn't occurred yet.
  Forum: By Share Code

Johnny H
Posted on: Nov 20 2019, 01:24 PM


Group: Member
Posts: 854

I have no idea where the actual locations are.

Just a little comic relief at the hastily-put-together presentation.
  Forum: By Share Code

Johnny H
Posted on: Nov 20 2019, 01:07 PM


Group: Member
Posts: 854

Did anyone find the map of the specialty centers a little..... off?

I have many questions about their choice of locations.
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Johnny H
Posted on: Nov 20 2019, 12:49 PM


Group: Member
Posts: 854

Interesting. Typically, trials involving healthy patients are phase I. Then again, safety data has already been established, which is also phase I.
  Forum: By Share Code

Johnny H
Posted on: Nov 20 2019, 12:11 PM


Group: Member
Posts: 854

Or hope for a recession.
  Forum: By Share Code

Johnny H
Posted on: Nov 20 2019, 11:56 AM


Group: Member
Posts: 854

Renumeration Resolution:

FOR: 9,612,120 votes 59.87%

AGAINST: 6,441,674 votes. 40.13%

Motion carried.

Did not vote or denied the right to vote: 2/3rds of shareholders, which is exactly what they wanted.
  Forum: By Share Code

Johnny H
Posted on: Nov 20 2019, 11:47 AM


Group: Member
Posts: 854

They still have to go through the IND and three phases of trials, but the process is significantly different for a prophylactic trial versus a therapeutic trial. The threshold for proving efficacy is a bit lower (as you don't want to induce the condition that you are trying to prevent during the trial), but it does require a large dataset. The 50 person trial is just the first step.
  Forum: By Share Code

Johnny H
Posted on: Nov 20 2019, 09:50 AM


Group: Member
Posts: 854

They aren't setting a good tone for the rest of the meeting.

That first sentence? In the United States, that's a criminal act.

For a publicly traded company, there's only one way to go about attracting like-minded and "compatible" long term shareholders: back-channel communication and sharing information that hasn't been released to market.

Words cannot describe how disappointed I am.

They had a chance to change for the better, and instead, they're doubling down.
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Johnny H
Posted on: Nov 20 2019, 09:30 AM


Group: Member
Posts: 854

This is why Malcolm Bull is making the big bucks now.
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Johnny H
Posted on: Nov 19 2019, 01:39 AM


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Posts: 854

De minimis compliance with Australian law,

But this one is going to have lasers, fireworks, a release of white doves upon Wolgen's entrance, and coolers full of White Claw for attendees.
  Forum: By Share Code

Johnny H
Posted on: Nov 18 2019, 02:41 AM


Group: Member
Posts: 854

You can safely discount anything this woman says.

She doesn't understand the difference between patents and market exclusivity, and yet she's authoring articles about it anyway. This personality type is particularly dangerous in any field, but especially investing. She doesn't know what she doesn't know, which is a perfect recipe for losing money.

In re: generics, there is exactly one place in the world capable of commercially manufacturing the implant right now: Evonik Birmingham Laboratories. It's safe to assume that Clinuvel has an exclusivity/non-compete agreement with them. It's standard industry practice.

Clinuvel keeps most of their manufacturing data secret. It would be nearly impossible to prove bioequivalence in an ANDA (generic application), nor would it be commercially viable to even try in such a small patient population.

Long story short, there will not be a generic version of Scenesse. Ever.
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Johnny H
Posted on: Nov 17 2019, 01:36 PM


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Posts: 854

Clinuvel letter to American Porphyria Foundation members.
Attached File(s)
Attached File  20191009_APF.pdf ( 120.31K ) Number of downloads: 161

 
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Johnny H
Posted on: Nov 15 2019, 04:33 AM


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Posts: 854

They're mostly the same patients. Clinuvel requested a waiver in a meeting with the FDA.
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Johnny H
Posted on: Nov 14 2019, 01:07 PM


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Posts: 854

The lack of a distribution network.

In particular, the mention in the action package of the "8 states" caught my attention. It's a reference to the locations of the clinical trial sites in the US. It appears that they have told the FDA that they will be treating patients at these locations rather than everywhere.

Hopefully it's only in the very short term, and they have plans for expansion.
  Forum: By Share Code

Johnny H
Posted on: Nov 14 2019, 11:12 AM


Group: Member
Posts: 854

You are correct. You don't get it.

US PBMs don't even run a cost-benefit analysis for drugs that cost under $100,000 per patient per year. They cut a check without batting an eye.

There are several barriers to rollout; pricing is not one of them.
  Forum: By Share Code

Johnny H
Posted on: Nov 13 2019, 07:59 AM


Group: Member
Posts: 854

You're looking at after hours trading, where the entire book is pulled. Your broker can't trade your order after hours unless you specifically request it.
  Forum: By Share Code

Johnny H
Posted on: Nov 13 2019, 04:05 AM


Group: Member
Posts: 854

The dichotomy is baffling. We have an absentee CEO who is also a micromanager.
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Johnny H
Posted on: Nov 12 2019, 09:40 AM


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Posts: 854

MT-7117 is an MC1R receptor agonist but not a melanocortin analog. It's a substituted pyrrolidine that is alleged to be orally active. Same mechanism of action: production of eumelanin for photoprotection.
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Johnny H
Posted on: Nov 12 2019, 04:31 AM


Group: Member
Posts: 854

Assuming that the ADR voting is real, and PunkassDerm's proxy wasn't a mistake....

Here's what I know so far.

There has not been an "unsolicited" proxy as of yet. Unsolicited means that your brokerage automatically receives the ballot, and then forwards that ballot to you.

So far, we know of one example, and it was solicited.

For foreign voting, US companies use a company called Broadridge to handle the ballots. As of today, there is nothing in the Broadridge database that indicates that CLVLY shares are votable. However, it seems that if brokers contact Broadridge manually, they are able to get the proxy forms and process the votes. It takes about a week.

If your brokerage's corporate reorganization department doesn't already have the contact information for Broadridge, their number is 800-464-8683.


Edit: Punkass beat me to it again. I am also an Apex predator. Maybe I need to switch to Ameritrade.
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Johnny H
Posted on: Nov 12 2019, 03:39 AM


Group: Member
Posts: 854

This is one of the things that I'm very concerned about. Mitsubishi Tanabe is a professional pharma company with nearly endless resources and experience. It won't take them 10 years to get their product to market. More like 2 years.

The obvious way for Clinuvel to deal with this competition (widening their "economic moat", if you will) is to get as many patients on Scenesse as possible. Reimbursement negotiations can wait. Give it away for free if necessary. Why? Because if US patients are being treated with Scenesse, they can't participate in Mitsubishi's phase III clinical trials. Strangle the competition in the crib, so to speak. Do it in the US, Japan, and anywhere else that Mitsubishi might try to conduct their trials. This is a very rare situation in which 2 companies are bringing an orphan drug to market that has the same mechanism of action. Clinuvel has first mover status, and they can't afford to squander their head start.

Am I confident in Clinuvel's ability to move quickly in the US? Nope. They've said that they're going to handle distribution internally, using their "trial and error" and "learn as you go" techniques. We quite simply don't have time for that.

Clinuvel has ZERO infrastructure in place in the United States. Clinuvel Inc's headquarters in the US is..... a house in Menlo Park. Clinuvel's "director of regulatory affairs" is... a real estate agent. That's right, a f#@$ing real estate agent. Clinuvel's contact number (which appears on the labeling insert shipped with packages of Scenesse) is.... that real estate agent's cell phone number.

Clinuvel needs to contract out with a professional organization with actual experience in distribution, and get this drug shipped NOW.






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Johnny H
Posted on: Nov 12 2019, 01:37 AM


Group: Member
Posts: 854

I know of at least one American who received a proxy ballot as of this morning, His broker is TD Ameritrade. I am with Etrade and Vanguard, and I have not received anything yet.

This is the first year I've heard of this happening, so Clinuvel MIGHT have changed their voting policy.

Please check your email, secure broker messaging, and snail mail to see if you might have received a ballot too.


Edit: disregard. I see Punkass covered it below. He should be at work by now. Lazy bum.
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Johnny H
Posted on: Nov 9 2019, 08:09 AM


Group: Member
Posts: 854

A little perspective on the compensation package and the $7.5 Billion market cap performance target:

If we hire SOMEONE ELSE to achieve it, Wolgen's stake in the company will still be worth over $420 million.
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Johnny H
Posted on: Nov 9 2019, 07:50 AM


Group: Member
Posts: 854

The obvious next question is: did they REALLY lie, or were they just incredibly misleading without breaking the law?

To answer this, I look back on a pair of posts I made in late 2018. I predicted that the FDA would accept the NDA filing and assign a PDUFA date no later than December 31st, 2018. I was pretty sure of it. Cocky, even. So, how was my prediction off by 1 week? I mean, I can count to 60, right?

I relied on information in the newsletter released on November 5th and published to the ASX website. Of course, most of the newsletter was glib and evasive garbage intended to deceive investors without explicitly lying. However, they weren't glib enough. They painted themselves into a corner with this statement:

"As a process, our teams, along with associated third parties, analyzed the retrieved data and provided answers to each individual question to satisfy these latest regulatory requests". Here, they are claiming to have resubmitted the NDA while still maintaining the fiction that they don't need to resubmit because nothing happened.

They are explicitly claiming that they have already provided everything to the FDA. PROVIDED. PAST TENSE.

This statement was released on Monday, Nov 5th, which is a Sunday in the USA. If true, this means that the LATEST POSSIBLE DATE they could have resubmitted the NDA was Friday, Nov 2nd in the USA. Of course, it is now a matter of public record that they actually submitted the application a week later, on November 8th.

Clinuvel knowingly released materially false information to the market. This, ladies and gentlemen, is a crime.


Do I really need to go over the statement about the supplier issue with the cosmetic line, or can we all agree that it's a lie too?


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Johnny H
Posted on: Nov 9 2019, 07:22 AM


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Posts: 854

In a stark departure from standard industry practices, Wolgen inexplicably called for a trading halt to announce the submission of the NDA. The decision was risky and ill-advised. As we all know, it backfired horribly. The NDA was not accepted for filing for another 7 months.

In order to save face, Wolgen created a fiction that the NDA was in some sort of FDA purgatory, and still on a first cycle review. He continuously promoted this fictitious narrative in a series of increasingly bizarre newsletters that were obviously designed to confuse shareholders. He promoted this fiction as recently as the annual report and the investor conference call.

I have long known that he was lying, but I have been unable to prove it.

Until now.

The approved NDA was submitted on November 8th, 2018. The NDA submitted on June 21st, 2018 was rejected.

To reiterate: THE NDA WAS APPROVED ON A SECOND CYCLE REVIEW.


Below is a screenshot of correspondence between FDA divisions during the 1st review (submitted June 21st, 2018). In this correspondence, the division is advising that it is deferring its portion of the review because they already know that it is being rejected in the 1st review cycle.

BY AUGUST 12, 2018, 53 DAYS INTO THE VALIDATION PERIOD, THE FDA HAD ALREADY DETERMINED THAT IT WAS GOING TO REJECT THE SUBMISSION.

Clinuvel did not publicly acknowledge the problem until September 5th, 2018, when they began their "the FDA has further questions" fiction.

A question I'm asking myself is: when is it OK to lie? Generally, I would excuse a lie if it was to protect trade secrets. However, this lie was PURELY TO SAVE FACE. WOLGEN PUT THE COMPANY AND ITS REPUTATION IN JEOPARDY TO PROTECT HIS EGO. It's absolutely unacceptable, and he continues to do it.







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Johnny H
Posted on: Nov 9 2019, 03:13 AM


Group: Member
Posts: 854

I'm going to do a writeup today and tomorrow.

Which topic would you and the rest of the board be more interested in reading about first? Incompetence or dishonesty?

I'll do one today and one tomorrow. But for now, I need to blow off some steam at the gym. This is not how I wanted to spend my day off.


I would have loved to address these issues privately at the AGM, but they banned me from attending as an investor. They gave 2 nonsense reasons at first, and then finally settled on "not enough room" as the reason I was not allowed to attend. I could still legally attend as the proxy of another shareholder (and my heartfelt thanks to those of you who offered your shares for me to do so), but it's too late to schedule a trip to Melbourne, and they probably would ignore my questions anyway.

  Forum: By Share Code

Johnny H
Posted on: Nov 9 2019, 02:34 AM


Group: Member
Posts: 854

I'm not going to sugarcoat it. It's pretty f@#%ing bad, and I'm not even halfway through.

I think we're way past the issue of compensation. It's time to seriously consider the possibility that we need new management.




  Forum: By Share Code

Johnny H
Posted on: Nov 9 2019, 12:13 AM


Group: Member
Posts: 854

(Part 3)

Edit:
3 of the 7 files are too large to attach as PDFs.

Originals here:
https://www.accessdata.fda.gov/drugsatfda_d...7_Orig1_toc.cfm
  Forum: By Share Code

Johnny H
Posted on: Nov 9 2019, 12:11 AM


Group: Member
Posts: 854

(Part 2)
Attached File(s)
Attached File  210797Orig1s000OEList.pdf ( 97.56K ) Number of downloads: 31

 
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Johnny H
Posted on: Nov 9 2019, 12:08 AM


Group: Member
Posts: 854

The FDA Action Package for Scenesse is now available on the FDA website. They posted it about an hour before the 30 day statutory deadline. I had an FOIA request in for it regardless.


I suggest that everyone read and become familiar with the various portions of the Action Package before making an informed vote on the resolution. It's a lot of reading, so I'll probably post a summary tomorrow.

(Part 1)
Attached File(s)
Attached File  210797Orig1s000AdminCorres.pdf ( 879.78K ) Number of downloads: 50
Attached File  210797Orig1s000RiskR.pdf ( 450.27K ) Number of downloads: 45
Attached File  210797Orig1s000NameR.pdf ( 1.3MB ) Number of downloads: 37

 
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Johnny H
Posted on: Nov 8 2019, 10:35 AM


Group: Member
Posts: 854

IIRC, the percentage of royalties due to Evonik increases as sales increase. That might be part of it.

They might also have inventory manufactured that is earmarked for distribution in the US, and is ready for packaging, labeling and batch release.
  Forum: By Share Code

Johnny H
Posted on: Nov 7 2019, 04:26 AM


Group: Member
Posts: 854

There's a difference between what the law says and what we, as shareholders, believe should be done. The question at hand isn't if Clinuvel is doing the bare minimum required by law. The question is: are they doing what's best for shareholders?

You are correct. They are under no obligation to answer any or every shareholder question. However, when they do, they are not entitled to lie.


As far as my last paragraph, perhaps you're right, and I worded it too strongly. My point is: I'm not interested in re-litigating the past, but rather, that things change going forward.

I have no interest in damaging the company, and I'm not selling my shares for several years. I believe in this molecule 100%. The company? Could be doing things a little better.
  Forum: By Share Code

Johnny H
Posted on: Nov 7 2019, 02:55 AM


Group: Member
Posts: 854

I remain optimistic that the board will be responsive to shareholder concerns. Bjildorp is already quite obviously aware of the issues.



  Forum: By Share Code

Johnny H
Posted on: Nov 7 2019, 01:38 AM


Group: Member
Posts: 854

No matter how badly they wish this company were private, it's not. WE own the company.

The board needs to decide if it's going to do its job and provide independent oversight. This vote isn't just about a grossly negligent compensation package for the CEO. The vote is about whether things will be business as usual. To me, business as usual is unacceptable. The status quo is to ignore shareholders. If you're lucky, maybe they'll acknowledge you by lying to you.

If they don't pull or changel the renumeration resolution, we have no choice but to vote NO ON EVERYTHING. If the board is unwilling or unable to provide independent oversight, it's time for a new board.

I'm going to give the letters that have been written a chance for consideration. I have some hope that they will be responsive.

If not, I'm going with plan B.

Clinuvel management: I know you read this site every day. You already suspect that I know things that you don't want me to know, and your suspicions are correct. You do not want me posting that information here. Do the right thing. Do not force my hand.

We have FDA approval now. Things must change.
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Johnny H
Posted on: Nov 6 2019, 08:50 AM


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Posts: 854

Looks like Wolgen is getting a $14 million payout today.

The timing on this is..... not smart.
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Johnny H
Posted on: Oct 30 2019, 01:57 PM


Group: Member
Posts: 854

Especially given that there will definitely be a recession in the next 4 years. It's not an if; it's a when.

Take out the recession clause, and I don't really have a problem with the performance rights. As written now, it's poison.
  Forum: By Share Code

Johnny H
Posted on: Oct 26 2019, 07:40 AM


Group: Member
Posts: 854

I called the broker today about CLVLF specifically. They escalated my question all the way to the head of the trading department, and he still didn't know. He forwarded the question to the research department, and they're getting back to me next week.

This situation isn't necessarily complicated, but it is unusual. My platinum relationship representative (or whatever he's called) had never heard of a sponsored ADR that's non-voting (although unsponsored are usually non-voting). As a result, they almost never get calls from clients wanting to convert ADR shares to foreign ordinary shares.

If there is any easy answer as to how to vote CLVLF shares, I'll be sure to post it here so that people know what to tell their brokers.
  Forum: By Share Code

Johnny H
Posted on: Oct 26 2019, 07:26 AM


Group: Member
Posts: 854

They'd also have to escalate the ADR from Level I to Level II to list on NASDAQ. Also, the ADR shares would get a vote. They do NOT want that. They also don't want to be an SEC reporting company. They've painted themselves into a corner, and would have to come clean about the OTC/cosmetics, and especially the timing of the NDA submission.
  Forum: By Share Code

Johnny H
Posted on: Oct 26 2019, 03:53 AM


Group: Member
Posts: 854

Based on the company's current situation and recent actions, I wouldn't expect a NASDAQ listing in the near future.
  Forum: By Share Code

Johnny H
Posted on: Oct 26 2019, 12:06 AM


Group: Member
Posts: 854

I'm going to call my broker to get clarification today.

Last year, I held a few thousand shares of CUV.AX through Interactive Brokers, and I never got anything in the mail.. Maybe it works differently for foreign holders.
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Johnny H
Posted on: Oct 24 2019, 11:59 AM


Group: Member
Posts: 854

Whoops. You're right. I just found it on page 16 of the deposit agreement. They can't vote unless you tell them to, and you can't vote unless Clinuvel tells them to let you.

Clinuvel simply has to tell BNY to allow ADR owners to vote, but they haven't. Odd, that. 5 million non-voting shares. It's almost like they want your money, but not your opinion.
  Forum: By Share Code

Johnny H
Posted on: Oct 24 2019, 10:08 AM


Group: Member
Posts: 854

The nominee forwards the voting materials to the beneficial owner, pretty much the same as a dividend. Clinuvel has no idea that I'm a shareholder, but a dividend is forwarded to me.

The only exception is the ADR. I'm the beneficial owner, but BNY Mellon controls the votes to my shares. HSBC Nominees is BNY Mellon's local (to Australia) custodian, so of the 10 million shares listed for HSBC, 5 million of those shares are BNY Mellon's and will (presumably) always vote along with the board's recommendation.

I have no idea who CommSec uses as a nominee, but it's probably one of the big ones.
  Forum: By Share Code

Johnny H
Posted on: Oct 24 2019, 09:19 AM


Group: Member
Posts: 854

The bank nominees are made up of individual shareholders, including you. Every little bit helps.
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Johnny H
Posted on: Oct 24 2019, 08:33 AM


Group: Member
Posts: 854

Poll:

Is anyone here going to vote YES on Resolution 4? (Approval of grant of Performance Rights to a related party: Chief Executive Officer Dr Philippe Wolgen)
  Forum: By Share Code

Johnny H
Posted on: Oct 21 2019, 05:20 AM


Group: Member
Posts: 854

An enterprising young lad appears to have registered the domain investclinuvel.com. Perhaps we can track him down and get him to publish it.
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Johnny H
Posted on: Oct 21 2019, 01:27 AM


Group: Member
Posts: 854

More importantly, a hostile party will never get 50% of the outstanding shares. Ever.
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Johnny H
Posted on: Oct 18 2019, 11:58 AM


Group: Member
Posts: 854

I don't like the looks of the recession clause. CUV is going to significantly outperform any biotech index no matter what.
  Forum: By Share Code

Johnny H
Posted on: Oct 18 2019, 08:58 AM


Group: Member
Posts: 854

Is anyone (or multiple people, ideally) willing to report misconduct to ASIC? I can't, because I don't trade shares on the ASX, and I don't have an Australian phone number to be contacted.

There is clearly some market manipulation going on with respect to CUV. Some participant(s), playing both sides of the market, is ensuring that the price goes down about $1 each day. Ever since the ASX 200 inclusion, this has been going on almost continuously, which hints that the responsible party is a recent entrant to the CUV shareholder registry.


Link to lodge a complaint here:
https://asic.gov.au/about-asic/contact-us/h...onduct-to-asic/

Click on "Report misconduct now"


The more complaints, the more attention this will get.






  Forum: By Share Code

Johnny H
Posted on: Oct 18 2019, 07:54 AM


Group: Member
Posts: 854

Since we are now living in the era of Real World Data.....

If off-label use for vitiligo is going to happen anyway, Clinuvel may as well collect the data on it and track patient progress. Not only would it bolster their FDA application for a new indication, but they would also be making money instead of spending it.
  Forum: By Share Code

Johnny H
Posted on: Oct 15 2019, 08:30 AM


Group: Member
Posts: 854

I thought it was going to be a resignation/retirement letter, but he's going to hand over the chairmanship "in due course".
  Forum: By Share Code

Johnny H
Posted on: Oct 14 2019, 03:50 AM


Group: Member
Posts: 854

I submitted a question to that effect for the conference call, and they declined to answer it.
  Forum: By Share Code

Johnny H
Posted on: Oct 11 2019, 12:41 PM


Group: Member
Posts: 854

There's an exemption for bona fide market making. They're exempt from the initial "locate" requirement, but still have to deliver the shares at settlement.

In the US, the complaint would go to FINRA. If there is in fact prohibited conduct, FINRA comes down hard.

Recently, I had some issues with a brokerage I no longer use. I complained to FINRA, and they dropped the hammer.
  Forum: By Share Code

Johnny H
Posted on: Oct 11 2019, 09:33 AM


Group: Member
Posts: 854

CLVLY 30% naked shorts today.
http://regsho.finra.org/FORFshvol20191010.txt

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Johnny H
Posted on: Oct 11 2019, 07:58 AM


Group: Member
Posts: 854

"Audio transcription"?

I'm going to have to send Mr. Bull a dictionary.
  Forum: By Share Code

Johnny H
Posted on: Oct 11 2019, 02:03 AM


Group: Member
Posts: 854

I was glad to see that Kendall Marcus signed the approval letter, even though she wasn't required to.

She looked the EPP patients in the eyes and listened to what they were saying.
  Forum: By Share Code

Johnny H
Posted on: Oct 11 2019, 12:33 AM


Group: Member
Posts: 854

Since you're already way ahead of me on this...

Is this routine, and happens to a lot of NMEs? Or is there something that would have triggered it?
  Forum: By Share Code

Johnny H
Posted on: Oct 11 2019, 12:12 AM


Group: Member
Posts: 854

Yeah, I was surprised to see that they required a cardiac repolarization study. I've never heard of that being a concern before.
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Johnny H
Posted on: Oct 10 2019, 12:27 PM


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The numbers are in.

25% of CLVLY traded today (Wednesday US) was naked shorting. That's one way to keep a lid on the price.

http://regsho.finra.org/FORFshvol20191009.txt
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Johnny H
Posted on: Oct 10 2019, 09:31 AM


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Yes. Also Miami, Dallas, Chicago, and Minneapolis.


Edit: I'd like to see a location in Los Angeles, possibly at UCLA or USC. In addition to being one of the most populous areas of the US, it would also put patients in the metropolitan Phoenix area within a 6 hour drive.
  Forum: By Share Code

Johnny H
Posted on: Oct 10 2019, 09:14 AM


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It's UT Galveston.

Locations for the Phase III confirmatory for EPP were:

University of Alabama
Birmingham, Alabama

UCSF
San Francisco, California

Henry Ford Medical Center
Detroit, Michigan

Mt. Sinai
New York, New York

Medical Center Cannon Research
Charlotte, North Carolina

University of Texas
Galveston, Texas

University of Utah
Salt Lake City, Utah
  Forum: By Share Code

Johnny H
Posted on: Oct 10 2019, 08:22 AM


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They'll be paying less, actually.

US Insurance will usually pay for the flights and hotels too. Now, they don't have to.


As far as expedited rollout, I would expect all of the clinical trial sites to be centers where patients are treated (at a minimum). The doctors are already trained, and they can use a similar supply chain.
  Forum: By Share Code

Johnny H
Posted on: Oct 10 2019, 06:12 AM


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Weigh by volume. ADR was 200k shares today, ASX was 1.5 million shares.

The ADR isn't very liquid, so a single buyer or seller can push the price quite a bit in either direction.
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Johnny H
Posted on: Oct 10 2019, 05:54 AM


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Investor Conference Call. 3 Parts. (part 4 is just the operator saying that there are no more questions)

Part 1
Part 2
Part 3
  Forum: By Share Code

Johnny H
Posted on: Oct 10 2019, 05:23 AM


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I tried to post a recording of the conference call, but the upload keeps rejecting audio files. Hmmm... I'll have to come up with something else
  Forum: By Share Code

Johnny H
Posted on: Oct 9 2019, 04:10 PM


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I guess they didn't want to answer my question.
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Johnny H
Posted on: Oct 9 2019, 03:52 PM


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North American vitiligo program is being restarted.
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Johnny H
Posted on: Oct 9 2019, 05:55 AM


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QUOTE
“six hours for patients receiving Scenesse and 0.75 hours for patients receiving placebo. “

8x



NICE had it at 6 additional minutes a day. Now, it shows 360 minutes. They're out of excuses.
  Forum: By Share Code

Johnny H
Posted on: Oct 9 2019, 04:56 AM


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This new data is absolutely critical to EPP patients getting reimbursed in the US.
It shows that Scenesse is 60 TIMES more effective than the original phase III data showed.

What could have been a struggle for patients is now a given.

Well done, Clinuvel. Bravo!
  Forum: By Share Code

Johnny H
Posted on: Oct 9 2019, 04:48 AM


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What were we angry about yesterday? Wolgen's compensation? I can't even remember anymore....
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Johnny H
Posted on: Oct 9 2019, 03:29 AM


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The price of CLVLF is up 11%. They still don't know.

Spread is now $2.50
  Forum: By Share Code

Johnny H
Posted on: Oct 9 2019, 03:23 AM


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And now.....

OPEN THE FLOODGATES
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Johnny H
Posted on: Oct 9 2019, 03:18 AM


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CLVLF is still trading at pre-approval prices. The marker makers don't know yet.
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Johnny H
Posted on: Oct 9 2019, 02:14 AM


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YES!

I was at the dentist a week ago in Torrance. I drove by both Bachem and Polypeptide on the way home. No US Federal Government license plates in the parking lot, but it was worth a look.


Side note: CLVLF is still trading if anyone wants one last top up. I bought 75 shares to see if it would go through, and it did.
  Forum: By Share Code

Johnny H
Posted on: Oct 9 2019, 01:52 AM


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If I understand that correctly, Clinuvel is notified first, and Clinuvel has to confirm that they received the notification. Only then is the press office notified, completing step 2 of the process.

If that's how this works, I don't see why Clinuvel wouldn't issue a press release at the time they confirm that they have received the notification.

It sounds like we're going to hear from Clinuvel first, but that's not going to stop me from refreshing the FDA page in the meantime.
  Forum: By Share Code

Johnny H
Posted on: Oct 9 2019, 12:28 AM


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I bet that we don't hear anything for several hours.

I'm glad that Australia changed their clocks a month before the US does. That's one less hour that I'll have to wait.
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Johnny H
Posted on: Oct 8 2019, 11:48 PM


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Time for some speculation:

Who thinks that Clinuvel already has the information?

It's entirely possible that they called for the trading halt anticipating that they were going to receive the news today.
  Forum: By Share Code

Johnny H
Posted on: Oct 8 2019, 11:35 PM


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Posts: 854

It looks CLVLF is still available to trade, although the Bid/Ask spread is over $1.


On a side note, without naming names, one of you texted me "CRL" while I was conducting my morning business on the toilet. I ran downstairs naked to get my laptop, only to find that it was a joke.

I assure you that justice will be swift and severe. Be afraid. Be very afraid.
  Forum: By Share Code

Johnny H
Posted on: Oct 8 2019, 10:13 PM


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Just logged on to E*trade. CLVLY is blanked out. There is no official announcement yet, but it looks like they're going to close the books.

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Johnny H
Posted on: Oct 8 2019, 10:21 AM


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Thanks. I might need you to call it tomorrow too. I don't want to be 20 minutes behind the party!
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Johnny H
Posted on: Oct 8 2019, 04:31 AM


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Does anyone know of a pill that can knock you out for about 24 hours? No reason.
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Johnny H
Posted on: Oct 7 2019, 11:19 AM


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"Term: 36 months Expiring 1 July 2022"

So the contract has already been in effect for 2 months, and they're just announcing it now?
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Johnny H
Posted on: Oct 7 2019, 10:03 AM


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I don't think they would have done it otherwise.

They'd be dealing with a shareholder revolt if they gave him that kind of money after a screwup.

And, note that all of the 4 incentives agreed upon are things that would happen after approval

-OTC sales
-New indications
-Licensing or distribution in new markets
-New molecules

This is a forward looking contract.
  Forum: By Share Code

Johnny H
Posted on: Oct 7 2019, 09:10 AM


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The contract is calculated in Singapore Dollars? Interesting....
  Forum: By Share Code

Johnny H
Posted on: Oct 7 2019, 08:38 AM


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Can anyone photoshop Wolgen's countdown clock?

That's beyond my skillset.
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Johnny H
Posted on: Oct 5 2019, 05:39 AM


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This article has a little bit of everything:
https://stockhead.com.au/health/clinuvel-sh...day-approaches/

Debt free, and tax free in the foreseeable future:

QUOTE
Clinuvel, better known to some by its former name of Epitan, has a novel treatment for rare cases of genetic skin disorders. It spent well over $100 million developing its product, and it is likely to be several years yet before it uses up all of its accumulated losses and will have to pay any company tax.


And for all of you short theorists:

QUOTE
But when good news emerges, short sellers can be forced to move quickly to buy back shares, squeezing the share price higher.

This occurred on Monday, when the shares in the heavily shorted Nufarm surged as much as a third when it sold a big chunk of its operations for more than$1.8 billion, catching short sellers off guard.


The future:

QUOTE
Still, with a handy $50 million in cash sitting on its balance sheet, there is always the chance of an acquisition as Clinuvel seeks to broaden its product profile, the broker has noted.






  Forum: By Share Code

Johnny H
Posted on: Oct 4 2019, 05:36 AM


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Translation. It looks like DeepL did a better job than Google Translate, so that's what I'm going with:

Individual case: VA-BD-SV/0305-A/1/2018
Shadowspringer Disease: No Cost Assumption for Medication
Mr. N.N. suffers from erythropoietic protoporphyria (EPP), also known as "shadow-springer disease". EPP is a very rare genetic metabolic disease in which people react to visible light with severe pain (similar to burning pain). Many sufferers protect themselves with long-sleeved shirts and long trousers, socks, gloves, scarves, etc. The light is visible in the skin and the skin is very painful. Despite this masking, prolonged exposure to the sun often leads to pain. It is estimated that there are about 25 to 60 patients with this disease in Austria.
The only effective drug for the treatment of EPP is the drug "Scenesse" (active substance afamelanotide). It has been approved by the European Medicines Agency since December 2014. However, both the Hauptverband der österreichischen Sozialversicherungsträger and the KA- Ges doubt the benefit of the drug. In contrast to this self-help groups at home and abroad as well as affected persons who use the drug themselves are convinced of the effect. The costs per treatment amount to around 14,000 euros. Depending on the number of treatments, the total cost is between 60,000 and 80,000 euros. According to the main association, Scenesse is a product to be used in the "intramural area". In Austria the treatment is carried out exclusively in the LKH Graz and in the University Hospital Innsbruck.
For treatment in hospitals, therefore, the health insurance carriers or the state funds (performance-oriented hospital financing) would also be responsible for assuming the costs. However, the KAGes pointed out that the outpatient form of treatment would also justify the assumption of costs by the social health insurance. In practice, there are individual solutions that deviate from the basic separation between intramural and extramural areas.
According to its own information, the KAGes treated about three applications for individual case approvals in March of the previous year, whereby two were approved and the application was rejected by Mr. N.N.. The KAGes thus bears the costs for the other two patients. In addition, one patient will be treated at the LKH Graz, but the costs will be borne by the Krankenfürsorgeanstalt der Bediensteten der Stadt Wien. Two other patients who were previously treated in Graz continued their therapy at the University Hospital Innsbruck, where the Gebietskrankenkasse Tirol assumed the costs.
Obviously, the medical treatment of the shadow-jumper disease is still little researched. The KAGes does not consider the additional benefit to be sufficient. The drug "Scenesse", however, seems to be a remedy for some of those affected.
The VA therefore appeals to find a colourful and uniform solution for the few Austrian EPP cases and to alleviate the suffering of those affected.
  Forum: By Share Code

Johnny H
Posted on: Oct 3 2019, 10:37 AM


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This is important to keep in mind:

"I will retreat in the notion that CLINUVEL will have all key ingredients to become a company of an order of magnitude larger than what it is now"

-Stan McLiesh, April 2019
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Johnny H
Posted on: Oct 3 2019, 05:25 AM


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Posts: 854

The FDA is following the law as written. In spite of some of the mythology that has been spread around here, they have no other choice.
3 month extension means a 3 calendar month extension, not 2 months and 28 days. They made a mistake, and they corrected it. If they didn't, other drug companies could sue for a shorter extension because Clinuvel got one.

To quote Dr. Wright, "Nothing has materially changed".


On another note, my dividend came through, and I did what probably everyone else here did: bought more shares.
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Johnny H
Posted on: Oct 2 2019, 10:19 AM


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I guess we'll find out if Malcolm Bull is worth the money they're paying him.
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Johnny H
Posted on: Oct 2 2019, 10:15 AM


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A week from today.

The FDA usually communicates after (US market) close. That leaves a 4 hour gap before trading commences in Australia.

I wonder if Clinuvel is going to request a trading halt, or decide to just roll with it if the FDA beats them to the announcement.

In any case, I agree with the sentiment below. The FDA wouldn't need 2 extra days to write a CRL. They would, however, need 2 extra days to issue an approval package.
  Forum: By Share Code

Johnny H
Posted on: Oct 1 2019, 01:42 PM


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We're getting into semantics here.

If the FDA issues a CRL, it's technically a rejection. However, I would consider it a delay.

The CRL lays out all the things that need to be corrected to gain approval, and I would expect Clinuvel to make those corrections and submit the NDA again as soon as possible. If the changes are relatively minor, the FDA does not require another full 6 month review cycle (Type I and Type II resubmissions). I don't have the PDF from the FDA in front of me right now, but from memory, I think that one of the resubmission categories only requires a 2 month review after the changes are submitted.

IF there is a CRL, however improbable it may be, it's most likely going to be because of CMC issues with the contract manufacturer, which is a quick fix (relative to other issues). We could still be on track for a summer rollout.

For the record, I think that a CRL is highly unlikely, as the FDA policy is to only grant 3 month extensions in cases where it is likely to result in a first cycle approval.



  Forum: By Share Code

Johnny H
Posted on: Oct 1 2019, 02:26 AM


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If it's not automatic, you'd be able to do it for a tiny fee.

You can already convert back and forth between CLVLY and CLVLF. Etrade charges 2 cents per share.

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Johnny H
Posted on: Oct 1 2019, 01:29 AM


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BNY Mellon (or contracting financial institutions) control how many shares are available in each market. If there is demand, it's entirely possibly that the NASDAQ volume will exceed the ASX volume.


But to your question specifically: the ADR becomes NASDAQ. Your ADR shares are still ADR, but they're automatically rolled over to the NASDAQ under the new ticker.

At the time of the new NASDAQ listing, CLVLY shares will be pulled from OTC Markets.
  Forum: By Share Code

Johnny H
Posted on: Oct 1 2019, 01:03 AM


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Well, this answers all of our questions about a NASDAQ listing:
https://www.avitamedical.com/uploads/pdf/Av...EPT19-Final.pdf

As of this morning, Avita Medical, an ASX listed company, is now dual-listed on NASDAQ.

QUOTE
AVITA Medical’s common stock will continue to trade uninterrupted on the Australian Stock Exchange (ASX) under the symbol “AVH.” Shareholders of AVITA Medical’s ADS previously traded on the U.S. OTC market under the symbol “AVMXY” do not need to take any action as the “AVMXY” shares will automatically move to the Nasdaq Capital Market and trade under the “RCEL” ticker symbol.


The stock is up 10% on the announcement.

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Johnny H
Posted on: Sep 30 2019, 07:08 AM


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If anyone is in a similar situation to me (does NOT want to sell after approval because the price will continue to go up), it might be worth talking to your bank to see what kind of loan programs they have.

I'm at BofA, but I'm shopping around. I talked to the loan manager at Chase on Friday, and they have something call a CAAP loan. Basically, they'll give you a loan based on the value of your securities. No income requirements, no liens on property.

I've been conflicted in that I might have money burning a hole in my pocket soon, but I absolutely do not want to sell. This might be an ideal solution.

Strongly considering, but still shopping around.

Good luck to all.
  Forum: By Share Code

Johnny H
Posted on: Sep 28 2019, 03:34 AM


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Typo. It's missing a zero, but otherwise pretty accurate.
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Johnny H
Posted on: Sep 24 2019, 04:51 AM


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Crazy idea: they're getting ready to be publicly traded in the US.

Prove me wrong, kids. Prove me wrong.
  Forum: By Share Code

Johnny H
Posted on: Sep 24 2019, 04:42 AM


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https://seekingalpha.com/article/4284940-cl...carlo-valuation
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Johnny H
Posted on: Sep 23 2019, 09:03 AM


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She has useful experience, which means free advice for Clinuvel. On the other hand, the experience is in the UK.

This is the second director in a row appointed and not elected. Not sure how I feel about that.
  Forum: By Share Code

Johnny H
Posted on: Sep 23 2019, 08:59 AM


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I talked to an FDA consultant this weekend, and I was told pretty much the same thing as everyone else.

If the PDUFA date is on a weekend, the FDA will communicate the decision after the end of the business day on Friday (which is Saturday in Oz).

Given Clinuvel's fondness for trading halts, I'm expecting a trading halt on a Monday, which would be today (ha! A man can dream), a week from today, or two weeks from today.


Reload ASX webpage. Wait 5 seconds. Reload ASX webpage again. Repeat until insanity.
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Johnny H
Posted on: Sep 20 2019, 08:32 AM


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It appears that the recently released prescription drug price control legislation introduced by House Democrats, in its current form, will not affect the pricing of Scenesse:
https://www.healthaffairs.org/do/10.1377/hb...19.459441/full/



QUOTE
The core of the House’s package is the authority it provides to the HHS Secretary to negotiate directly the prices of prescription drugs (Section 101). This authority is not unlimited. The Secretary is only empowered to negotiate prices on the 250 branded drugs “with the greatest cost to Medicare and the whole U.S. health system” that lack “a generic or biosimilar competitor.”
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Johnny H
Posted on: Sep 19 2019, 08:50 AM


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The delays and lack of initiative. I'll refrain from posting the exact quote because the nuance is lost. It didn't sound that bad when I listened to it. It looks a lot worse in writing than it actually is.
  Forum: By Share Code

Johnny H
Posted on: Sep 19 2019, 06:47 AM


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Posts: 854

QUOTE
Does anybody have access to Slingshot Insides?

https://twitter.com/JMac_SI/status/1173993866392932352


Long story short:
-The French doc has been treating EPP for 30+ years, and was one of the researchers who discovered the genetic defect.

-He's retired now, which is why he decided to speak on the record.

-He's seen the new data, and declined to discuss it until it's in the public domain (did not specify if it was because of non-disclosure or if he was doing so of his own volition)

-He firmly believes that the FDA will approve

-He would have designed the clinical trials differently, namely, using prodromes as an endpoint instead of a painful reaction

-He has administered 3 separate arms of Scenesse clinical trials since 2006

-He's friends with Wolgen

-He's not impressed with Clinuvel's business decisions thus far generally, and specifically, in his home country of France.

That's about it unless. If anything else comes to mind, I'll update.
  Forum: By Share Code

Johnny H
Posted on: Sep 19 2019, 01:20 AM


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The ethics committee rejected that model outright on the grounds that it was inhumane.
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Johnny H
Posted on: Sep 19 2019, 12:07 AM


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This is what I have been waiting for, and it's great news!

I wasn't worried about the efficacy data for FDA approval.... the approval of Vylessi even after a botched phase 3 removed all doubt.

What I was worried about was reimbursement. Generally, US insurance will cover any new FDA approved drug, but when you get into the really expensive drugs, it gets iffy.


The 3 largest PBMs in the United States (CVS Health, Express Scripts, and United Health/OptumRx/Catamaran, collectively making perscription drug coverage decisions for over 180 million Americans) all have a general policy that they will automatically cover any FDA approved drug that costs $100,000 or less per QALY. With the Scenesse phase 3 data alone, the cost of Scenesse was over $100,000 per QALY. The actual calculation was disputed (NICE made a calculation of over $1 million per, but they obviously fudged the numbers to avoid paying for Scenesse).

This new real world data shows the real efficacy of Scenesse, and this is the data that is being evaluated by the FDA, and, later by ICER (the actuarial non profit calculating the cost per QALY).


The phase 3 data showed a median increase of 6 minutes of sun exposure. The real world date shows 360 minutes?!?!?!?!?!? That makes Scenesse 60 TIMES MORE EFFICACIOUS than previously thought. This means reimbursement will be automatic. No stupid games like in Europe. Clinuvel might even be able to charge more per dose in the United States, and they have the justification to do so: 5 additional years of costs to gain approval.
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Johnny H
Posted on: Sep 18 2019, 11:40 PM


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BNY Mellon (and other brokerages with which they have a written agreement) can issue/cancel AD receipts and take on or release deposited CUV shares on demand. They can also pre-release up to 30% of total receipts before they've taken on the corresponding share deposits in Australia.

There are zero transactional costs, so it costs them nothing to do so, and they can pocket the difference in profit. If there's an exchange rate adjusted price difference of more than a few percent, they'll close the gap and make money on it.
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Johnny H
Posted on: Sep 18 2019, 08:08 AM


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I don't expect a significant change in short interest leading up to the PDUFA date.

Whether they're using proprietary software or off-the-shelf software calibrated to the ASX 200, I doubt it knows what a PDUFA date is. They're trading strictly on technicals. Given Clinuvel's P/E and penny dividend, it makes sense that the software thinks it's appropriate to short 5% of outstanding capital.

When Clinuvel starts raking in cash from US sales, I expect the shorts to drop well below 2%.
  Forum: By Share Code

Johnny H
Posted on: Sep 17 2019, 11:57 PM


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Bullseye.

If more than a million shares suddenly gets locked into.a mutual fund forever, and the volume goes up? That's on-lending. The funds are loaning out their own shares to the trading desk to act as market makers.

These guys make their money on volume across the entire ASX 200. They have no idea what Clinuvel does or that a PFUDA date is coming. And yes, their algorithm is good.
  Forum: By Share Code

Johnny H
Posted on: Sep 13 2019, 04:00 AM


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It's going to be #1.

I really hope that they don't use the same consultant that they used for the trial data, PASS management, and the NDA submission.

Icon PLC sucks, and I hope Clinuvel ends the relationship as soon as possible. I've heard from 2 different people in the last day that their reputation is horrible, and large share of the blame for the delays undoubtedly belongs to them.
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Johnny H
Posted on: Sep 12 2019, 09:44 AM


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Since we're running out of things to talk about on no news, I thought I might share this:

I bought a sample of YKL-06-061 from a reputable laboratory. I swabbed it on my skin (the part of my wrist that is concealed from the sun by my watchband) for 8 days in a row.

No effect. None. I tried it with both ethanol and DMSO as solvents.

For those unfamiliar with YKL-06-061, it is a SIK inhibitor that induces melanogenesis, and was optimized to penetrate the skin.
https://www.ncbi.nlm.nih.gov/pmc/articles/P...irENImFA_32aHY8


Conclusion: definitely not a near term threat to Clinuvel, and not a long term threat either. AFAIK, nobody is attempting to commercialize it anyway.
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Johnny H
Posted on: Sep 11 2019, 11:55 PM


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The takeover is coming from inside the building!
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Johnny H
Posted on: Sep 10 2019, 03:16 PM


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It looks like Clinuvel has committed to presenting their real world PASS data on Scenesse efficacy at ICPP
Attached File(s)
Attached File  448dh4q8vrn1yn.pdf ( 154.46K ) Number of downloads: 153

 
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Johnny H
Posted on: Sep 10 2019, 05:06 AM


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Yes, from today (Monday in Europe). On the program, the 1st session.

Clinuvel is a bronze sponsor. As Sharelooker noted, they have the same booth as in Barcelona.
Attached thumbnail(s)
Attached Image


 

Attached File(s)
Attached File  ICPP2019_sinottica.pdf ( 115.23K ) Number of downloads: 42

 
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Johnny H
Posted on: Sep 10 2019, 03:08 AM


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Welp... too late to edit my comment.

I would like to clarify that I am NOT at the conference.
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Johnny H
Posted on: Sep 10 2019, 01:48 AM


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Today's presentation.

Speaking is Dr. Iqbal Hamza, Ph.D., professor at the University of Maryland. https://hamza.umd.edu/node/3

We've heard quite a bit from the clinical side (Drs. Minder and Lim MD, et al). It will be interesting to hear from the research side.
Attached thumbnail(s)
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Johnny H
Posted on: Sep 8 2019, 09:09 AM


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I expect a series of rapid fire announcements after approval covering the lack of communication going back 2 years. Cosmetics, new indications, acquisitions.... hopefully we'll be fully disclosed by the annual shareholder meeting.


Where in the Rockies?

I just put some mud tires on my GX (LC Prado to people in AUS), and am looking to explore Colorado and Utah (I know it's not the Rockies) next summer.
  Forum: By Share Code

Johnny H
Posted on: Sep 8 2019, 12:30 AM


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A couple things to keep in mind:

-Clinuvel is currently a single drug company. The share price is going to move A LOT more than if a giant Pharma company received approval for one of many drugs in their portfolio.

-FDA approval is far more significant than an EMA approval under "exceptional circumstances". A model extrapolating the share price post FDA approval from Scenesse's EMA approval would likely severely underestimate what the actual price is likely to be.

And one more thing... EMA approval was 5 years ago (my, how time flies!), so my data isn't very deep. I don't have price resolution down to the day from 5 years ago, and certainly not intra-day. I don't even know what the price resolution is from my broker is from 2014, but it is very smoothed.

That said, here is the share price for CLVLY before, during, and after EMA approval. IMO, this low resolution misses a good portion of the bump. I distinctly remember selling a large chunk of shares above $4.50 on the day it was announced. IIRC, a block of my shares went for around 4.80, which would have been more than double the price of the prior day. I also remember the shares trading at $5 at one point. I took a screen shot, but... that was 3 laptops ago.

Anyway...

Clinuvel is in a rare situation, so all we can do is guess. My best guess: the absolute worst case scenario after FDA approval is a 75% bump, which is the low end of what my price data is showing. As far as the best case? I couldn't even guess, but way better than 75%.

Attached thumbnail(s)
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Johnny H
Posted on: Sep 7 2019, 08:05 AM


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If you want more fun reading about that, there's a filing somewhere in EDGAR that's pretty hilarious. Shkreli didn't have nearly enough cash on hand, and had to take out a massive line of credit to buy all of those Clinuvel shares. And then.... he had to unload all of those shares in a hurry to cover other debts. It was beautiful.
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Johnny H
Posted on: Sep 7 2019, 01:19 AM


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It looks very similar to my financial projections.


Keep the jokes coming, guys. It's all we have for the next month.
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Johnny H
Posted on: Sep 6 2019, 10:34 AM


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Posts: 854

There's a place nearby that's the "adult" version: http://thethermalclub.com/track/


Quite frankly, if I'm sitting out on the patio enjoying the weather, I'd rather get hit by a golf ball than get crushed by a race car.
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Johnny H
Posted on: Sep 6 2019, 08:53 AM


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Posts: 854

CRL- I'm buying these for my kids: https://gokartsusa.com/Voodoo-Race-Go-Kart.aspx

Approval- House and Go kart track to go with them
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Johnny H
Posted on: Sep 5 2019, 07:26 AM


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Posts: 854

"You heard the monkey. Make the trade!"

https://www.youtube.com/watch?v=u196yHvR8K8
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Johnny H
Posted on: Sep 5 2019, 03:30 AM


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Posts: 854

"Economic Moat: None"

WTF? Clinuvel's economic moat is wider than the @!#ing Pacific Ocean!

Real world data, patient registries, 98% continuation rate, 7 year exclusivity, the only drug produced commercially at Evonik Birmingham, etc etc etc.


I wonder what target price they'd come up with if they actually understood Clinuvel's business model....
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Johnny H
Posted on: Sep 4 2019, 08:31 AM


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Posts: 854

Clinuvel went so far as to request a trading halt for an NDA submission. In hindsight, that wasn't a great idea (to put it mildly).

I guess it would come down to:
-when Clinuvel is notified
and
-if there is a risk of trading on MNPI before the announcement is released to market


Hopefully, they get their press release right on the 1st try.
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Johnny H
Posted on: Sep 4 2019, 07:38 AM


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Posts: 854

They can't announce another delay. The FDA is allowed to extend the PDUFA date once, and only once.

There's no guarantee that the FDA will approve the drug by the Oct deadline (the PDUFA date is a target date in which the FDA is required to issue 90% of their decisions. Scenesse could be in that other 10%). The FDA can be late, but there can be no additional extension.

At this point, nothing would surprise me. The decision could come early if the FDA has received all of the information they requested. Conversely, if Clinuvel is still submitting responses, the decision could come late. However, if there is no news by the October deadline, I would consider it a good sign. Frustrating, but a good sign. The FDA isn't going to further delay a CRL pending submission of additional material. Instead, they'd issue a CRL that says "You should have submitted X on time. We cannot approve the application as submitted at this time.".

In general, early = approval, late = approval, right on time = approval or CRL. I'm going to start losing sleep right around Friday of that weekend. The trading day closes in AUS before the business day opens in Silver Spring, so, I'm guessing a trading halt on Monday or Tuesday AUS if things are right on schedule.
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Johnny H
Posted on: Aug 31 2019, 01:54 PM


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Posts: 854

The FDA can propose draft labeling as a condition of approval. So, in that sense, they can provide feedback right up until the very last day of the NDA review.

Compared to the other parts of the review, the labeling process isn't very rigorous at all, especially if you look at what they did to Palatin as an example. There is no guessing game, or any sort of trying and failing until the sponsor gets it right. They basically pull out a pen with red ink, mark out the parts they don't like, and tell the sponsor what changes to make. It's basically a test where the FDA gives up the answers if they aren't correct on the first try.


That said, I wouldn't be surprised if the labeling was a bit behind schedule. Sharelooker has found at least 2 cases on clinicaltrials.gov where Clinuvel is still submitting revised data for their EPP trials. It might take some time to review.

On the other hand.... It costs around $2.5 million to complete an entire NDA review. Clinuvel does not have to pay that fee, as Scenesse is an orphan drug. The FDA bears the entire cost of the review of Scenesse. I doubt they're very keen on having to do it again. The FDA has about 2.5 million reasons to approve Scenesse on the first go.

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Johnny H
Posted on: Aug 31 2019, 05:47 AM


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Posts: 854

I just had this conversation with someone about a week ago. The conclusion was this:

Clinuvel disclosed the labeling date that the FDA provided. That's it.

There's no agreement to disclose when or if the FDA keeps the deadline, nor to reveal the contents of the communication.

I don't expect to hear anything. If we do hear something... yeah, it's probably good news.
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Johnny H
Posted on: Aug 31 2019, 05:34 AM


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Posts: 854

There are too many unknowns for us as shareholders to even begin to contemplate compensation packages.

And.... the timing is not in our favor.

Assume approval on or before the PDUFA date. Of course, we'll be ecstatic. But.... after all of these delays, I'll expect nothing less. If we get a CRL, my focus would be towards replacing ineffective employees, because at this point, any outcome other than approval is unacceptable.

So again, assuming approval, we find out a little more than a month before the shareholder meeting. With little more than a month, the FDA might not even have the public portion of the Drug Master File posted yet. That means that we, the shareholders, won't have concrete information on what caused the initial 4 month filing delay (from August '18 to January '19), and, to a lesser extent, the 3 month PDFUDA date extension (although that's far less of a mystery). It would be unethical, bordering on corporate malfeasance, to hold a shareholder vote on compensation for upper management when the shareholders aren't privy to this information.

Did Wolgen kick-save an FDA approval, or was he responsible for some of the delays? Or both? I get the need for secrecy before FDA approval but.... If Clinuvel is considering about giving away a sizable chunk of the company in executive compensation, they need to come clean with the shareholders. Otherwise, it's an automatic "no" vote.

And I'm not just talking about secrecy around the FDA correspondence. I'm talking about EVERYTHING. The mystery cosmetic line that seems to have disappeared, the clinical trials for other indications, the European negotiations.... everything.

If Clinuvel disclose won't disclose this information in time for the shareholder vote, there shouldn't be a vote at all.
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Johnny H
Posted on: Aug 29 2019, 11:35 AM


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Posts: 854

All Clinuvel has to do is send a letter to BNY Mellon authorizing the vote. There's a reason they haven't.
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Johnny H
Posted on: Aug 29 2019, 07:38 AM


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Posts: 854

Dr. Minder speaking at Clinuvel's sponsored symposium today. Tomorrow: the keynote.
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Johnny H
Posted on: Aug 29 2019, 02:40 AM


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Posts: 854

What am I looking at here? Are those houseplants in Clinuvel's Photocare display?
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Johnny H
Posted on: Aug 28 2019, 12:28 PM


Group: Member
Posts: 854

I like what Bjildorp had to say.

He's trying to keep Wolgen onboard with another 3 year contract.
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Johnny H
Posted on: Aug 27 2019, 09:11 AM


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Posts: 854

LOL at the adverse events.

Malignant melanoma in situ:
Placebo=1
Scenesse=0

Not taking Scenesse causes cancer. QED.


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Johnny H
Posted on: Aug 27 2019, 12:45 AM


Group: Member
Posts: 854

Even better: As part of the Vylessi NDA review, the review team called in the DDDP to consult on that exact issue, and they were the ones who issued the favorable opinion.

Reminder: our entire NDA is being reviewed by DDDP.

Read their response to the question about skin malignancies at the end. It's basically "eh... an occasional mole check is fine":
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Johnny H
Posted on: Aug 26 2019, 05:55 AM


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Posts: 854

I'm 95% sure that the newsletters are templated, and the latest one was probably mostly written about 2-3 months ago with some minor changes. There are at least 4 giveaways in the FDA update.

Most of the "news" is not time specific, and could have been written anytime. Wolgen probably has a whole library of these to cut and paste.

"The nature of the discussions is collaborative and there is frequent exchange of information and clarifications on data submitted, for example on specifications and on the meaningful benefit against the side effect profile of SCENESSE®"

The FDA is doing FDA stuff.

"Ongoing interactions between the US Food and Drug Administration (FDA) and our scientific teams continue to take place as the final outcome date"

Stuff continues to happen as time progresses.

"All in all, our teams are working around the clock to ensure that this historic review comes to a positive conclusion. For now, the CLINUVEL teams are preparing documentation and internal processes for two possible outcomes."

People are doing the jobs they get paid to do.

"Central to all these processes remain people, those in our offices who have built and implemented the quality and pharmacovigilance systems for product distribution in the European Union. Most of these professionals are being involved in preparing for US market access in the near or distant future"

Employees are key to preparing for things that might occur sometime in the future.


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Johnny H
Posted on: Aug 26 2019, 05:31 AM


Group: Member
Posts: 854

The outstanding "Q&A Clinical use post-MA" that was originally scheduled for May and delayed for 2 months was apparently completed some time between the July 11th newsletter and August 20th newsletter.
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Johnny H
Posted on: Aug 25 2019, 03:38 PM


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Posts: 854

Mea culpa. I misread the guidance. The meeting has to actually take place by today. We’ve been in the clear for a few weeks.
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Johnny H
Posted on: Aug 24 2019, 07:44 AM


Group: Member
Posts: 854

I'm not sure how this is even possible, but equity short interest in CLVLF has skyrocketed above 200,000 shares, which is over 3 months' worth of average trading volume. Maybe the shares were borrowed for cross-border arbitrage or ADR conversion?
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Johnny H
Posted on: Aug 23 2019, 08:05 PM


Group: Member
Posts: 854

The ADR administrator fee is the lesser of:

10% of the US exchange rate adjusted dividend per share
or
$.02 per ADR share.

Meaning the fee is a fixed 10% for dividend amounts up to and including $.20, where it maxes out at $.02/share. The marginal cost of ADR fees for any dividend amount above $.20 is zero. The higher the dividend, the lower the fee.

Additionally, under the deposit agreement, Clinuvel has to pay an equivalent fee to BNY out of pocket for each calendar year during which they do not issue a dividend. So... the fee is getting paid one way or another. A token dividend provides Australian shareholders with additional value, as it shifts the costs of the Depository Services from all shareholders to the ones who are actually using the service.

It's worth noting that CLVLF shares do not get charged a fee, and receive the same exchange rate adjusted dividend as Australian shares.

A $.05 dividend would provide much more shareholder value to me than Clinuvel sitting on a pile of unused cash. It could attract a new class of investors, and, at the very least, I could buy a few hundred more shares. As long as Clinuvel is able to adequately fund growth and expansion activities with the cash that keeps coming in the door, I'm fine with whatever dividend they decide to pay.






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Johnny H
Posted on: Aug 23 2019, 06:02 PM


Group: Member
Posts: 854

Thank you! I don't know how I missed your June 5th post. It has everything!

It seems that they really earned that CRL. 2 jaw droppers:

-"verifying the reliability of Cmax data and providing justification for non-applicability of the agreed-upon and prespecified Cmax secondary endpoints"
If you think you need some wiggle room to shift your endpoints after the fact when the results don't go your way.... for the love of god, DO NOT agree to pre-specified endpoints with the FDA. Changing agreed-upon endpoints without justification is a 100% guaranteed way to elicit a negative reaction from FDA reviewers and voting committee members.

-"obtaining definitive evidence pre-approval via an ambulatory blood pressure monitoring study as to whether TLANDO causes a clinically meaningful increase in blood pressure"
A testosterone replacement therapy with known cardiac side effects, intended for older men.... and they didn't do something as simple as a proper blood pressure monitoring study???



It appears that their advisory committee meeting was already scheduled before the PDUFA date was extended (but had not yet taken place), so perhaps the FDA couldn't determine if 1st cycle approval was likely until the results of the Adcom vote.

Either way, if this is the one counter-example to the trend, I'm pretty excited. Like you said, the chances of approval went up after Clinuvel announced the extension.

The fact that the FDA communicated to Clinuvel from the outset that it had no intention of calling an AdCom meeting indicates to me that the FDA is not on the fence about this decision at all.

And.... If the FDA were to call an Advisory Committee meeting, which they can do up until the end of the business day today (Friday, 5PM EST), the results of the Adcom would probably be unanimously in favor of approval. The FDA is well aware of this from the patient workshop (one of the first of its kind ever).

In hindsight, I think that if not for the contract manufacturing issues, it's possible that the FDA would have been on track for an expedited approval (approval a full month or more ahead of the original 6 month deadline). The labeling deadline was 3 months before the original target date, and now, it's only 1 month before. You have to wonder what the FDA was planning to do with those extra 2 months.

Anyway... I thought I would start getting more nervous as we near Oct 6, but the opposite is true.


Thanks for the data points!






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Johnny H
Posted on: Aug 23 2019, 11:52 AM


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Posts: 854

Every incidence I've been able to find is from 2012 or earlier, and it appears to be so because the law has changed.

Congress has to reauthorize the Prescription Drug User Fee Act (PDUFA) every 5 years, and each time they do, they make changes and improvements.

Every example of a PDUFA extension later resulting in a CRL in the first cycle (that I have been able to find, anyway) occurred in 2012 or earlier, which was under the laws of PDUFA IV (the 4th reauthorization, legally in force from 2008-2012).


PDUFA V was approved in 2012 and in legally in force from 2013 to 2017. Currently, PDUFA VI is legally in force from 2018-2022.

Both PDUFA V and PDUFA VI have the specific language: "FDA’s decision to extend the review clock should, except in rare circumstances, be limited to occasions where review of the new information could address outstanding deficiencies in the application and lead to approval in the current review cycle."

I can't find the exact text for the laws in PDUFA IV, but I would assume that the language is not in there. I CAN confirm that the language was was NOT in PDUFA III (see attached).

It would appear that the FDA adopted the policy of only extending the review when it would lead to 1st cycle approval sometime in 2013 ish.

So... the question is... have there been any recent (last 5 years) PDUFA extensions that later resulted in a CRL? If so, what were the rare circumstances?

I still haven't been able to find any. Anyone else?

This almost seems too good to be true. There has to be at least once example that we can discuss and learn from.

If not.... beer me... because this might be a done deal.
 
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Johnny H
Posted on: Aug 22 2019, 03:52 AM


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Posts: 854

This is more in response to Wolgen's statement in the newsletter:

"At this stage an Advisory Committee is not planned but again, the FDA reserves – at this late stage of the review – its right to call an Advisory Committee if it concludes that a further independent opinion is needed."

He's right. The FDA has the right to call AdComm, up until August 25th... this Sunday.
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Johnny H
Posted on: Aug 22 2019, 02:50 AM


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Posts: 854

I found some CRLs from back in 2010-2011, but that was before the FDA guidance was issued.

I can't find a single instance of a CRL under current PDUFA VI guidance.
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Johnny H
Posted on: Aug 22 2019, 02:48 AM


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Posts: 854

So, there is a lot of talk about AdComs and PDUFA extensions. I highly recommend that anyone interested in these matters read the FDA guidance I posted below. I'm only about halfway through it, but there is a bunch of useful information on how this process works.


Among the useful information I've come across so far:

-The PDUFA date can be extended once, and only once. (yes, the FDA can miss their own target date if they have not completed the review, but they cannot extend the date again)

-The FDA can announce an Advisory Committee Meeting up to 2 months before the PDUFA date (standard review), or 6 weeks before the PDUFA date (priority review).

As this pertains to Clinuvel, it means that the FDA can announce an Advisory Committee meeting any time up until.... this Sunday. After that, we're out of the woods (not that I am particularly concerned about it; just one less thing to worry about)

There's some stuff about the Signatory Authority in the guidance as well, but I haven't read and digested that part yet.
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Johnny H
Posted on: Aug 21 2019, 08:09 AM


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Posts: 854

Clarification on the press release I linked below:

I just looked it up. That language comes directly from the FDA guidance itself.

See page 5 of attached PDUFA Commitment letter (guidance and procedures for Fiscal Years 2018-2022)

I have to say that I'm pretty happy about this.
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Johnny H
Posted on: Aug 21 2019, 04:46 AM


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Posts: 854

I did a quick google search of PDUFA extensions to see how common it is, and what the outcome generally is.

The first 3 pages of results led me to:

Orilissa

Solriamfetol

Inbrija

Zulresso

Ruxolitinib

Selinexor, and

Zerenex.

All received a 3 month PDUFA extension, and then were later approved in that 3 month window(1st cycle approval, no CRL).

In addition, Xeris Pharmaceuticals received a 3 month PDUFA extension for the FDA review of Gvoke. New PDUFA date is September 10th, 2019. The language in their investor press release is interesting:
https://www.globenewswire.com/news-release/...-for-Gvoke.html

"According to FDA’s current PDUFA Performance Goals, an FDA decision to extend the review period typically is limited to situations where review of the new information could address an outstanding issue(s) and lead to approval in the current review cycle."


Perhaps we're in an even better position for approval than I had previously thought (in my opinion, chances for approval were already above 90%).

Does anyone know of a drug that received a 3 month PDUFA extension and then was later denied? I haven't found one yet. I'll keep looking.
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Johnny H
Posted on: Aug 20 2019, 10:01 AM


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Posts: 854

Key takeaways:

-They're going to handle distribution of Scenesse in the US own their own- Good. The FDA is going to like that.

-Potential expansion of the IR department- Good for share price.... if they use it to its full potential, which we all know that they might not.

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Johnny H
Posted on: Aug 19 2019, 03:42 PM


Group: Member
Posts: 854

Not sure what you're asking, but current FDA guidance revision list is here, see 4000.4 Rev. 1
https://www.fda.gov/about-fda/center-drug-e...procedures-mapp
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Johnny H
Posted on: Aug 19 2019, 02:33 PM


Group: Member
Posts: 854

ASIC is showing 2.76% as of August 13, for a total of 1.35 Million shares.

https://asic.gov.au/Reports/Daily/2019/08/R...AggShortPos.pdf


At the top:
"Disclaimer: No responsibility is accepted for any inaccuracies contained in the matter published."


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Johnny H
Posted on: Aug 19 2019, 08:41 AM


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Posts: 854

It's not a meeting so much as it is a response to what Clinuvel has proposed, and the response will be in writing. Clinuvel provides a proposal on post-marketing in the initial NDA, and the FDA provides commentary on the proposal, if necessary.

See page 10 of attached FDA guidance on how to submit an NDA.

Clinuvel is not required to provide any notice to shareholders whatsoever, although I'd be highly suspicious if they didn't.

By the time we get to post-marketing, it's pretty much a done deal. The FDA isn't going to waste time on labeling and post-marketing if they aren't going to approve it first cycle. A CRL would focus on actual deficiencies rather than a hypothetical approval.
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Johnny H
Posted on: Aug 17 2019, 10:58 AM


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Posts: 854

We're bulletproof on efficacy. It was my biggest fear a few years ago, but the least of my worries now.

Compared to some of the drugs that have been approved by the FDA recently, Clinuvel is light years ahead on efficacy, and..... it's for an ultra-orphan indication.
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Johnny H
Posted on: Aug 15 2019, 03:41 PM


Group: Member
Posts: 854

Totally agree, with one thing to add in re: arbitrage.

The ADR agreement allows for up to 30% "pre-release" (read: counterfeit) CLVLY shares, entirely at BNY Mellon's discretion. As an American, I find this entirely offensive. Pre-release isn't subject to the usual REG-SHO short reporting requirements. There's no way to determine how much of the float is actually "real".
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