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Johnny H
Posted on: Yesterday, 10:20 AM


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


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

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


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

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

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


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

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

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

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


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2/3rds of that was me.

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


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


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

Los Angeles, Detroit, and Aventura, FL.

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

In Miami (Aventura), the location is here.

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


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

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


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


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

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

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

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


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


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Question for the Aussie finance/accounting guys:

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


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


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


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

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

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

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

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

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

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


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


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


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

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

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

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

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


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


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Same odds I gave Verharven.


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


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It's not true.

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


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

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


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


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

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


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


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


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


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

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


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


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


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


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

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


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


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


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

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

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

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

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

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

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

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

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

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

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

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


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

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

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


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

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

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

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

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

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

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


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

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

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

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

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


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


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

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


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


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It's still better than the US operations.

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


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


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


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Roughly translated, the item on the agenda is:

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


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Wild guess:

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

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

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


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


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EU regulations only require a QP for batch release.

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

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


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

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

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


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


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"could serve as an important surrogate parameter"

You're definitely on to something there.

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

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

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


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


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

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

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

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

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


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

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

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

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

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


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

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





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


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

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

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

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

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

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


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

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

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

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

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


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

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

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

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


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

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

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


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


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


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

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


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

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

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


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


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

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


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

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

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

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

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


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

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


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


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

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


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


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

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

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

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


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

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

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


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Implications of the bill are zero.

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

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

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





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


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

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

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

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

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


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


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

Stan McLiesh, Chair Letter, November 20th, 2019

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

Phillipe Wolgen, Newsletter regarding the same time period.



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


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From Pharmacy Benefits Manager Prime Therapeutics:

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


More evidence that the alleged 2H21rollout was a typo.
Attached File(s)
Attached File  Oct_19_Specialty_Pipeline_Update_NL_.pdf ( 206.86K ) Number of downloads: 131

 
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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: 43

 
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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: 64

 
  Forum: By Share Code

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


Group: Member
Posts: 907

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: 907

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: 907

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: 907

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

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


Group: Member
Posts: 907

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: 907

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: 907

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: 907

Or hope for a recession.
  Forum: By Share Code

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


Group: Member
Posts: 907

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: 907

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: 907

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: 907

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


Group: Member
Posts: 907

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: 907

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.
  Forum: By Share Code

Johnny H
Posted on: Nov 17 2019, 01:36 PM


Group: Member
Posts: 907

Clinuvel letter to American Porphyria Foundation members.
Attached File(s)
Attached File  20191009_APF.pdf ( 120.31K ) Number of downloads: 187

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


Group: Member
Posts: 907

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: 907

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: 907

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: 907

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: 907

The dichotomy is baffling. We have an absentee CEO who is also a micromanager.
  Forum: By Share Code

Johnny H
Posted on: Nov 12 2019, 09:40 AM


Group: Member
Posts: 907

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.
  Forum: By Share Code

Johnny H
Posted on: Nov 12 2019, 04:31 AM


Group: Member
Posts: 907

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.
  Forum: By Share Code

Johnny H
Posted on: Nov 12 2019, 03:39 AM


Group: Member
Posts: 907

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: 907

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.
  Forum: By Share Code

Johnny H
Posted on: Nov 9 2019, 08:09 AM


Group: Member
Posts: 907

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.
  Forum: By Share Code

Johnny H
Posted on: Nov 9 2019, 07:50 AM


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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: 907

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: 907

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: 907

(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: 907

(Part 2)
Attached File(s)
Attached File  210797Orig1s000OEList.pdf ( 97.56K ) Number of downloads: 34

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


Group: Member
Posts: 907

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: 56
Attached File  210797Orig1s000RiskR.pdf ( 450.27K ) Number of downloads: 64
Attached File  210797Orig1s000NameR.pdf ( 1.3MB ) Number of downloads: 38

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


Group: Member
Posts: 907

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: 907

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: 907

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: 907

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.
  Forum: By Share Code

Johnny H
Posted on: Nov 6 2019, 08:50 AM


Group: Member
Posts: 907

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

The timing on this is..... not smart.
  Forum: By Share Code

Johnny H
Posted on: Oct 30 2019, 01:57 PM


Group: Member
Posts: 907

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: 907

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: 907

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: 907

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: 907

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.
  Forum: By Share Code

Johnny H
Posted on: Oct 24 2019, 11:59 AM


Group: Member
Posts: 907

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: 907

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: 907

The bank nominees are made up of individual shareholders, including you. Every little bit helps.
  Forum: By Share Code

Johnny H
Posted on: Oct 24 2019, 08:33 AM


Group: Member
Posts: 907

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: 907

An enterprising young lad appears to have registered the domain investclinuvel.com. Perhaps we can track him down and get him to publish it.
  Forum: By Share Code

Johnny H
Posted on: Oct 21 2019, 01:27 AM


Group: Member
Posts: 907

More importantly, a hostile party will never get 50% of the outstanding shares. Ever.
  Forum: By Share Code

Johnny H
Posted on: Oct 18 2019, 11:58 AM


Group: Member
Posts: 907

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: 907

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: 907

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: 907

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: 907

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: 907

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: 907

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

  Forum: By Share Code

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


Group: Member
Posts: 907

"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: 907

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: 907

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: 907

Yeah, I was surprised to see that they required a cardiac repolarization study. I've never heard of that being a concern before.
  Forum: By Share Code

Johnny H
Posted on: Oct 10 2019, 12:27 PM


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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

Part 1
Part 2
Part 3
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Johnny H
Posted on: Oct 10 2019, 05:23 AM


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

And now.....

OPEN THE FLOODGATES
  Forum: By Share Code

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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.

  Forum: By Share Code

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

"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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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
  Forum: By Share Code

Johnny H
Posted on: Oct 3 2019, 05:25 AM


Group: Member
Posts: 907

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


Group: Member
Posts: 907

I guess we'll find out if Malcolm Bull is worth the money they're paying him.
  Forum: By Share Code

Johnny H
Posted on: Oct 2 2019, 10:15 AM


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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.

  Forum: By Share Code

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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.

  Forum: By Share Code

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

Typo. It's missing a zero, but otherwise pretty accurate.
  Forum: By Share Code

Johnny H
Posted on: Sep 24 2019, 04:51 AM


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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


Group: Member
Posts: 907

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.
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