Registered Members Login:
   
Forgotten Your Details? Click Here To Recover +
Welcome To The ShareCafe Community - Talk Shares And Take Stock With Smart Investors - New Here? Click To Register >

4 Pages (Click to Jump) V   1 2 3 4 >

Johnny H
Posted on: Today, 05:55 AM


Group: Member
Posts: 672

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

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

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

The FDA is doing FDA stuff.

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

Stuff continues to happen as time progresses.

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

People are doing the jobs they get paid to do.

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

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


  Forum: By Share Code

Johnny H
Posted on: Today, 05:31 AM


Group: Member
Posts: 672

The outstanding "Q&A Clinical use post-MA" that was originally scheduled for May and delayed for 2 months was apparently completed some time between the July 11th newsletter and August 20th newsletter.
Attached thumbnail(s)
Attached Image

Attached Image



 
  Forum: By Share Code

Johnny H
Posted on: Yesterday, 03:38 PM


Group: Member
Posts: 672

Mea culpa. I misread the guidance. The meeting has to actually take place by today. We’ve been in the clear for a few weeks.
  Forum: By Share Code

Johnny H
Posted on: Aug 24 2019, 07:44 AM


Group: Member
Posts: 672

I'm not sure how this is even possible, but equity short interest in CLVLF has skyrocketed above 200,000 shares, which is over 3 months' worth of average trading volume. Maybe the shares were borrowed for cross-border arbitrage or ADR conversion?
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Aug 23 2019, 08:05 PM


Group: Member
Posts: 672

The ADR administrator fee is the lesser of:

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

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

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

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

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






  Forum: By Share Code

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


Group: Member
Posts: 672

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

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

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

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



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

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

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

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

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

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


Thanks for the data points!






  Forum: By Share Code

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


Group: Member
Posts: 672

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

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

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


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

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

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

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

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

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

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

If not.... beer me... because this might be a done deal.
 
  Forum: By Share Code

Johnny H
Posted on: Aug 22 2019, 03:52 AM


Group: Member
Posts: 672

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

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

He's right. The FDA has the right to call AdComm, up until August 25th... this Sunday.
  Forum: By Share Code

Johnny H
Posted on: Aug 22 2019, 02:50 AM


Group: Member
Posts: 672

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

I can't find a single instance of a CRL under current PDUFA VI guidance.
  Forum: By Share Code

Johnny H
Posted on: Aug 22 2019, 02:48 AM


Group: Member
Posts: 672

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


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

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

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

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

There's some stuff about the Signatory Authority in the guidance as well, but I haven't read and digested that part yet.
  Forum: By Share Code

Johnny H
Posted on: Aug 21 2019, 08:09 AM


Group: Member
Posts: 672

Clarification on the press release I linked below:

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

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

I have to say that I'm pretty happy about this.
Attached thumbnail(s)
Attached Image


 

Attached File(s)
Attached File  PDUFA_VI_FINAL_Committment_Letter.pdf ( 262.53K ) Number of downloads: 32

 
  Forum: By Share Code

Johnny H
Posted on: Aug 21 2019, 04:46 AM


Group: Member
Posts: 672

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

The first 3 pages of results led me to:

Orilissa

Solriamfetol

Inbrija

Zulresso

Ruxolitinib

Selinexor, and

Zerenex.

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

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

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


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

Does anyone know of a drug that received a 3 month PDUFA extension and then was later denied? I haven't found one yet. I'll keep looking.
  Forum: By Share Code

Johnny H
Posted on: Aug 20 2019, 10:01 AM


Group: Member
Posts: 672

Key takeaways:

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

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

  Forum: By Share Code

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


Group: Member
Posts: 672

Not sure what you're asking, but current FDA guidance revision list is here, see 4000.4 Rev. 1
https://www.fda.gov/about-fda/center-drug-e...procedures-mapp
  Forum: By Share Code

Johnny H
Posted on: Aug 19 2019, 02:33 PM


Group: Member
Posts: 672

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

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


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


  Forum: By Share Code

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


Group: Member
Posts: 672

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

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

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

By the time we get to post-marketing, it's pretty much a done deal. The FDA isn't going to waste time on labeling and post-marketing if they aren't going to approve it first cycle. A CRL would focus on actual deficiencies rather than a hypothetical approval.
Attached File(s)
Attached File  4000.4_Rev_1_cleared_by_OCP_OTS_ORP.pdf ( 307.45K ) Number of downloads: 31

 
  Forum: By Share Code

Johnny H
Posted on: Aug 17 2019, 10:58 AM


Group: Member
Posts: 672

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

Compared to some of the drugs that have been approved by the FDA recently, Clinuvel is light years ahead on efficacy, and..... it's for an ultra-orphan indication.
  Forum: By Share Code

Johnny H
Posted on: Aug 15 2019, 03:41 PM


Group: Member
Posts: 672

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

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

Johnny H
Posted on: Aug 15 2019, 10:37 AM


Group: Member
Posts: 672

Naked shorting is counterfeiting. Period.
  Forum: By Share Code

Johnny H
Posted on: Aug 15 2019, 02:43 AM


Group: Member
Posts: 672

Translated from German to English.

If there are errors, blame Microsoft.

Attached File(s)
Attached File  English.pdf ( 1.16MB ) Number of downloads: 208

 
  Forum: By Share Code

Johnny H
Posted on: Aug 14 2019, 07:40 AM


Group: Member
Posts: 672

Well, they probably should have registered the chivere.com domain. They didn't, and now somebody is squatting and wants 5000 bucks for it.

They did, however, register the tsumoyle.com domain in March of 2018.


I would volunteer to work at Clinuvel FOR FREE to help avoid mistakes like this.
Attached thumbnail(s)
Attached Image

Attached Image



 
  Forum: By Share Code

Johnny H
Posted on: Aug 13 2019, 09:08 AM


Group: Member
Posts: 672

Minus Sinus:
If you're reading this, Evonik Birmingham is in Birmingham, Alabama, USA, not Birmingham, UK.

Thanks for the article! Good stuff!
  Forum: By Share Code

Johnny H
Posted on: Aug 13 2019, 06:42 AM


Group: Member
Posts: 672

Uh oh.

I suppose I'll have to use my real name at the AGM, otherwise, they might kick me out.
  Forum: By Share Code

Johnny H
Posted on: Aug 13 2019, 04:58 AM


Group: Member
Posts: 672

You have got to be F@!#ing kidding me!

Unbelievable.

They got in trouble for doing the exact same thing with the bioequivalency trial at Prism in 2010.

The reason they had to resubmit is that they had the trial data in the wrong format. The FDA has changed their data submission standards SEVERAL times since 2010.

I would be extremely pissed right now if I believed that this particular trial was critical to getting approval.

Still, though, this is inexcusable.
  Forum: By Share Code

Johnny H
Posted on: Aug 11 2019, 12:03 AM


Group: Member
Posts: 672

I'm just some random guy on the internet, and I don't work in biotech.

If I was able to find this information, anyone who matters found it a long time ago.


Also, I wouldn't be posting any of this information unless I were sure that we were less than 2 months away from approval.
  Forum: By Share Code

Johnny H
Posted on: Aug 10 2019, 04:28 AM


Group: Member
Posts: 672

Mea Culpa:

It looks like I was wrong about the API manufacturing location. Thanks to some significant help from Investek, I think we finally found the correct location, and I requested the records this morning. Will share what I find as soon as I get it (hopefully before the labeling deadline).


Investek had to go all the way back to 2008 to find the information that tipped us off.


Why was it so difficult to find this information? Clinuvel wants it this way.

See attached policy adopted in 2012.


Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Aug 9 2019, 09:59 AM


Group: Member
Posts: 672

So, as I said before, this is a long shot, and I'm not 100% sure I have the correct facility location, but...

This is the only peptide manufacturing facility in the United States that I know of that has been inspected since Clinuvel's NDA was filed. Further, the founder of the company was co-listed as an inventor with Wolgen on one of Clinuvel's patents.

To reiterate, I'm not 100% sure that this is the correct location.


That said, there was one incredibly minor observation that wouldn't be a factor in the PDUFA delay. It would take less than a day to fix.


Long story short: I went digging for potentially bad news and didn't find any.
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Aug 7 2019, 11:47 AM


Group: Member
Posts: 672

1 month until labeling. 2 months until decision time.

I'm trying to track down some info on the API manufacturing in the meantime. It's a long shot, but I heard that there was a VAI on site there as well. Will post what I find as soon as I get it.
  Forum: By Share Code

Johnny H
Posted on: Aug 1 2019, 09:02 AM


Group: Member
Posts: 672

OK. 4th and final document. Sorry for posting these in reverse order. I'm posting them as I read them (which I'm not supposed to be doing at work).

Attached is the original FDA request for CMC information. The request is dated February 8th, 2019. The letter references a reply by Evonik on August 29, 2018, of which I do not have a copy. This reply would have been in reference to the original facility inspection that took place in the validation period last July-August.

The only things that jump out at me are that:

-in item #1, it appears that Evonik did not include sufficient supporting documentation to address the observations in its previous response, and the FDA had to specifically request it.

-in item #3, it appears that communications about the temperature data were verbal only after the initial inspection. I don't know enough about the inspection process to know if it's out of the ordinary to issue important instructions verbally without documentation. It seems a little odd to me. However, the instructions are quite important: "The CDER review team is concerned with this risk. Please provide your CAPA plan." This is the strongest language used in any of the FDA communications with Evonik.


Again, sorry for the posting order. If you read them in the opposite order that I posted, it all makes a lot more sense.
Attached File(s)
Attached File  r_NOL_Evonik_3012757951_RAI_dated_2_8_19_Redacted.pdf ( 87.38K ) Number of downloads: 223

 
  Forum: By Share Code

Johnny H
Posted on: Aug 1 2019, 07:05 AM


Group: Member
Posts: 672

If you go by the dates alone.... The FDA requested a response by Friday, May 17, 2009, which was less than 8 weeks from the target date. That tells me that the FDA is able to come to a decision within 8 weeks of receiving the requested CMC information.

Evonik provided self-imposed deadline of Tuesday, July 23rd to implement the changes requested. 8 weeks from July 23rd is... September 24th.

It's entirely possible that we could have an early approval date, but it's dependent on the timely completion of other tasks such as labeling. Also, this assumes that Evonik met their own deadline. We have no way of knowing if they did.

I personally believe that early approval is a strong possibility, and I'm shaking the couch cushions for spare change to see if I can squeeze in one last buy.
  Forum: By Share Code

Johnny H
Posted on: Aug 1 2019, 04:59 AM


Group: Member
Posts: 672

"This is the document you got from the FDA through your connections to the FDA"

Do you not remember the entire discussion about FOIA, and how anyone can get the information if they want? Go back and read again. I literally woke up to find this information in my mailbox THIS MORNING. I didn't message ANYONE, I decided to share it with everyone here.

"20 days ago you strongly implied to the whole board the data you got was damaging about the manufacturing response."

No, I said the exact opposite. I suggest that you go back and read everything again, because your understanding is.... lacking.


Edit: the post below is a response to NewToCli.
Attached thumbnail(s)
Attached Image



 
  Forum: By Share Code

Johnny H
Posted on: Aug 1 2019, 04:45 AM


Group: Member
Posts: 672

Evonik's response submitted on May 15th indicated that the changes would be in place by July 23rd, 2019, which is further evidence that this is the cause of the PDUFA extension. The FDA would not have been able to approve the NDA without this information.

See attached, and reference "due date"
Attached File(s)
Attached File  r_NOL_Evonik_3012757951_RAI_Response_dtd_5_15_19_Redacted.pdf ( 517.15K ) Number of downloads: 345

 
  Forum: By Share Code

Johnny H
Posted on: Aug 1 2019, 03:27 AM


Group: Member
Posts: 672

That's the case whenever a contract manufacturer is used.

Wolgen stated that the bulk of the FDA's questions were regarding CMC, and that falls under the purview of Evonik.

Evonik has every incentive to get this right. Clinuvel is the flagship customer for the Birmingham facility. Evonik invested $50 million into this facility in the last 4 years alone; they're not going to be able to make a return on that investment and attract new customers if Scenesse doesn't get approved.

I would note that Evonik's February response to the FDA was VERY thorough. The FDA was satisfied with the answers to all of their questions..... except for one: the CAPA for temperature data.

Evonik's response to question #3 (see attached) was what required additional information.

It appears that they corrected all of the other issues that were noted last summer, including inappropriate software permissions (item 1), unjustified deviations from written process control procedures (item 2), bioburden testing and sampling methods (see item 3), and the preventative maintenance plan (see item 4).

Should Evonik had been more thorough in answering question #3? Absolutely. Especially when question #3 contained the phrase "The CDER review team is concerned with this risk. Please provide your CAPA plan."

Frustrating, but it's in the past now. The FDA has the information they want.







Attached File(s)
 
  Forum: By Share Code

Johnny H
Posted on: Aug 1 2019, 01:28 AM


Group: Member
Posts: 672

Well, this one took a little longer, but it's finally here.

The manufacturing issues appear be limited to Evonik's CAPA (corrective and preventive action plan). On May 3rd, the FDA requested an updated CAPA plan, as the one submitted by Evonik in February was deemed inadequate. Evonik did not provide a reply until May 15th, which is more than 2/3rds of the way through the PDUFA period.. That's late enough in the process to trigger a 3 month extension.


Will post more on this when I get a chance.
Attached File(s)
Attached File  r_NOL_Evonik_3012757951_RAI_dated_5_3_19_Redacted.pdf ( 221.07K ) Number of downloads: 212

 
  Forum: By Share Code

Johnny H
Posted on: Jul 26 2019, 01:18 AM


Group: Member
Posts: 672

The bank has to own or control the shares. Shares held by the bank as custodian are not SEC reportable.
  Forum: By Share Code

Johnny H
Posted on: Jul 25 2019, 08:40 PM


Group: Member
Posts: 672

Update from Morningstar on changes in Fund/Institutional ownership of Clinuvel as of the end of last month.

Note: this data comes from mandatory SEC filings submitted by the companies/funds themselves. US based funds and institutions are required to periodically report their holdings to the SEC, as well of the holdings of all foreign subsidiaries they control (hence the SEC reporting for Vanguard Investments Australia Ltd, a subsidiary of The Vanguard Group, which is registered in the US). Morningstar just scrapes the SEC filings and compiles the data.

This list only includes SEC reporting funds/institutions registered in the United States, which is a small fraction of the total shareholders of Clinuvel.

The data on this list is also limited to direct ownership of CUV shares traded in the primary Australian market. US registered companies are not required to report CLVLY holdings to the SEC, as the CLVLY ADR is an SEC non-reporting security (over-the-counter status).

Interestingly, due to a recent ruling, CLVLY is also now a de-facto ASX non-reporting security as well (under the recent ASX ruling, because they retain voting rights on the underlying CUV shares on deposit, BNY Mellon is now reported in ASX filings as having controlling interest of all CLVLY shares on issue). Substantial shareholders and institutional owners of CLVLY are no longer required to include CLVLY shares in ASX filings when calculating changes in substantial holding or total shares held. The CLVLY ADR is pretty much the wild west, and there's no way determine beneficial ownership. No SEC reporting, no ASX reporting, and no company shareholder registry.

That said, even though this dataset only covers a small portion of potential institutional buyers (US registered, SEC reporting, direct holders of stock in a foreign domiciled biotech company, traded on a foreign exchange in a foreign currency), IMHO the increase was a pleasant surprise for this reporting period..... almost 400,000 shares. Not bad for a company with effectively zero investor relations and a reputation for secrecy.
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Jul 25 2019, 02:31 AM


Group: Member
Posts: 672

Looks like Dr. Henry Lim is presenting as well.
  Forum: By Share Code

Johnny H
Posted on: Jul 24 2019, 04:53 AM


Group: Member
Posts: 672

Ah.... So is this is the 5 year renewal for Marketing Authorization, and not the annual safety re-assessment.

So possible outcomes are a requirement to renew again in 5 years, or unlimited validity (no future requirement to renew). Nothing to do with PASS, it seems.
  Forum: By Share Code

Johnny H
Posted on: Jul 24 2019, 02:56 AM


Group: Member
Posts: 672

Still, though, the fact that it's even up for discussion is amazing.

I expected PASS for... I don't know, at least a decade or more.

This bodes very well future EU sales, and is a very good sign in re FDA approval.
  Forum: By Share Code

Johnny H
Posted on: Jul 24 2019, 02:12 AM


Group: Member
Posts: 672

Exactly. The data has to be overwhelmingly positive for this to happen.

This is s pretty big deal.

Hopefully, this will solve some of the "capacity issues", and eventually they'll be able to administer Scenesse outside of specialty centers.

From the EMA website:

*EDIT- Assuming the decision is in our favor. As far as I can tell, no opinion has been issued yet.
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Jul 20 2019, 12:14 AM


Group: Member
Posts: 672

Clinuvel tweeting about rare diseases in the UK:
https://twitter.com/ClinuvelNews/status/115...1012218880?s=20
  Forum: By Share Code

Johnny H
Posted on: Jul 18 2019, 07:57 AM


Group: Member
Posts: 672

I had considered it, but...

Most likely, they'll just delete the erroneous statements without an editor's note. I'd rather leave up the neon sign advertising that this guy is an idiot.


Also.... the guy has 17 twitter followers. Total. Sharecafe's CUV forum has 450 visitors PER HOUR. We're probably the only people who have read the article, and we all agree: it sucks.
  Forum: By Share Code

Johnny H
Posted on: Jul 18 2019, 04:13 AM


Group: Member
Posts: 672

This PTN?
https://www.prnewswire.com/news-releases/pa...-300333434.html

His twitter bio says he's a student: https://twitter.com/biotech_geeks

I guess he has some more learning to do.

The MC1R receptor is a G protein-coupled receptor. GPCRs are trans-domain, which is the exact opposite of what he describes.

From wikipedia, the ultimate arbiter of knowledge: "G protein–linked receptors (GPLR), constitute a large protein family of receptors that detect molecules outside the cell and activate internal signal transduction pathways"


So his statement "The acetylation at the N-terminal serine helps the drug to diffuse through cell membranes" indicates that he hasn't the slightest idea how Scenesse works. And yet, he wrote an article about it anyway.

If he's that wrong about something so basic, it's safe to assume that he's wrong about everything else, which in a sense, is good news for us.
  Forum: By Share Code

Johnny H
Posted on: Jul 18 2019, 02:26 AM


Group: Member
Posts: 672

There's this gem in the first paragraph:

"we expect the bubble to burst right after the PDUFA date."


And this little tidbit:

"The acetylation at the N-terminal serine helps the drug to diffuse through cell membranes"



This guy is so stupid he's not even wrong.



  Forum: By Share Code

Johnny H
Posted on: Jul 17 2019, 03:55 AM


Group: Member
Posts: 672

I had to up the bid 4 times. Oh, well.


At least I don't have to worry about missing an early approval now.
  Forum: By Share Code

Johnny H
Posted on: Jul 17 2019, 03:41 AM


Group: Member
Posts: 672

Me.

I would have done it sooner, but I didn't have the money until now.
  Forum: By Share Code

Johnny H
Posted on: Jul 15 2019, 03:27 AM


Group: Member
Posts: 672

There are 3 different parts to the manufacturing.

The API, the implant, and the packaging/labeling/batch release.

The API and the implant have always been manufactured in the United States. Clinuvel chose to use Catalent UK for packaging and batch release through their UK subsidiary for a number of reasons. After Brexit, they chose to move the UK subsidiary to Ireland and the packaging/batch release to Germany.

In theory, the API and packaging could be done in Europe. However, the implant will be manufactured at Evonik Birmingham for the foreseeable future. There is no comparable facility in Europe that can extrude the implants commercially.


GMP is a broad term that covers everything from medicines, devices, up to and including animal feed manufacturing. CMC has a GMP component, but it's much more involved. Evonik Birmingham does have a EudraGMP certificate, but that's essentially meaningless as far as FDA approval goes.

Post approval? Who knows. Maybe this agreement will be helpful, but for now, the FDA is going to do its own legwork.
  Forum: By Share Code

Johnny H
Posted on: Jul 14 2019, 04:50 AM


Group: Member
Posts: 672

I'm not sure what kind of foliage you can get away with in Taxachusetts, but the Costa Rican design is quite nice:
https://lucaslagoons.com/category/custom-po...tured-projects/
  Forum: By Share Code

Johnny H
Posted on: Jul 13 2019, 08:07 AM


Group: Member
Posts: 672

One other takeaway.

Last paragraph of Page 2: "The FDA’s proposed labelling can be expected – as per FDA’s correspondence of 31 May – by 6 September." (presumably, this is the same correspondence notifying Clinuvel of the extension, as that also occurred on May 31st)


So, now we have a new labeling deadline that's less than 2 months away. Interestingly, the original labeling deadline was 3 months prior to the PDUFA target date. Now, it's only one month prior to the new October PDUFA target date.

AFAICT, once the labeling requirements are communicated, it's a done deal, and approval is imminent. I'm marking my calendar.
  Forum: By Share Code

Johnny H
Posted on: Jul 10 2019, 11:46 AM


Group: Member
Posts: 672

Anyone who wants updates, IM me your email. It looks like this is going to get worse before it gets better.
  Forum: By Share Code

Johnny H
Posted on: Jul 10 2019, 11:42 AM


Group: Member
Posts: 672

A couple of IMs, meaning more than one? Go ahead. Post them. You have my permission.

I IM'ed you once, which I told you I was going to to do, publicly, because you wanted to argue about the RTF. You didn't "out" anything. I told you I wasn't interested in a public argument. I IM'ed you explaining why.



Just FYI, there are at least 10 regular posters here who know who I am. Real name, baby and family pictures, etc. I didn't ask them to vouch for me, and they didn't offer. Why do you think that might be?





Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Jul 10 2019, 10:08 AM


Group: Member
Posts: 672

Sorry, not directed at you. You have my respect.

You were replying to one of our soon-to-be-banned resident trolls.

I'm in the busy season at work; no time for nonsense.
  Forum: By Share Code

Johnny H
Posted on: Jul 10 2019, 08:31 AM


Group: Member
Posts: 672

I'm not sure which version of his post you're responding to, because he edited it a few times, but...

It's bizarre that I've touched such a nerve.

There is no bad news to be found. We already got the bad news. Remember the 3 month delay? Remember how our drug was going to be approved by yesterday?

Many of us are sizable investors in this company, and we've been very patient. I don't think it's out of the ordinary to try and figure out WHY we've recieved the bad news (recieved: past tense; it already happened). Somehow, that makes me "short". Honestly, I don't care.

I expect that the moderators will take the trash out any day now. They had some problems with the system, but I assume they're aware of the issue now.

I only have contacts for about 15 of you here. PM me if you wish; I'd love to be able to share any information I come across without the conversation being derailed by malcontents.
  Forum: By Share Code

Johnny H
Posted on: Jul 9 2019, 12:29 PM


Group: Member
Posts: 672

Sure. First of all, almost all NDA correspondence is confidential. They're not subject to FOIA or public records requests, the exception being Advisory Committee meetings, which are public hearings by definition and law. In that respect, I was kind of hoping that Clinuvel would have an AC, as it would give us a window into the proceedings.

What IS a matter of public record are facility inspection records. You can search the database here: https://www.accessdata.fda.gov/scripts/inspsearch/

From that search, you can figure out when you need to get more information. They only classify the sites as NAI, VAI, or OAI (AI is for "Action Indicated", "N", "V", and "O" stand for No, Voluntary, and Official, respectively).

If you get anything other than No Action Indicated, you know there's a problem, and you can use the FOIA to find out exactly what the problem is (or, was).

In a case like Evonik Birmingham, Clinuvel is the only commercial client at this point, so you can assume that any "responsive" replies to the FOIA request will give you the information that you need.
  Forum: By Share Code

Johnny H
Posted on: Jul 9 2019, 08:40 AM


Group: Member
Posts: 672

It's a matter of public record. Unfortunately, the records are hard to get. You either have to appear in person at a reading room in Rockville, Maryland (after calling ahead to confirm they have what you're looking for), or you can apply by mail, and get a response (eventually).

Pulling records doesn't interfere with the NDA process in any way. In fact, the last time I did it, I was told that I was the 3rd person to request the same records that week. All of the big fish are doing it. I'm just a little fish sharing what I find.
  Forum: By Share Code

Johnny H
Posted on: Jul 9 2019, 08:11 AM


Group: Member
Posts: 672

"Very sad/maddening that we have no freaking idea what the latest delay was actually about"

Hopefully, I'll have an answer in a week or so. I got a call from the FDA early this morning, and it was a little bit different from the last time around. I'm used to dealing with the FDA branch chief in Maryland, and she'll usually only give me redacted 483's.

This morning, I got a call from Legal Admin, and they seemed to be open to releasing any new 483's plus correspondence and other documentation. It was pleasantly surprising. I explained what I was looking for and why, and they immediately agreed to expand the search.

I won't know what they find until it shows up in the mail, but hopefully it will answer some questions.

In the meantime, maybe Clinuvel can clear some of this up via their newsletter; it would be much more professional than investors finding out through an Internet forum.
  Forum: By Share Code

Johnny H
Posted on: Jul 3 2019, 12:58 AM


Group: Member
Posts: 672

I'll thank you to leave me out of this.
  Forum: By Share Code

Johnny H
Posted on: Jul 2 2019, 04:10 AM


Group: Member
Posts: 672

As far as I'm concerned, bremelanotide belongs to Amag now. Palatin is only getting single digit % royalties on the sales (it could break 10% in the absolute best case scenario).

There are pros and cons to partnering and licensing. Yes, Palatin had an experienced company help them get the drug approved quickly.... but..... at quite a cost.
  Forum: By Share Code

Johnny H
Posted on: Jul 1 2019, 06:28 AM


Group: Member
Posts: 672

Speaking of which, I just submitted the paperwork to pull the FDA's inspection records for Evonik Birmingham again. It should take about 2 weeks, and I'll post what I find.

I had only planned to do it once, but with this latest delay, there's probably new information in the inspection reports.
  Forum: By Share Code

Johnny H
Posted on: Jun 27 2019, 07:28 AM


Group: Member
Posts: 672

The FDA's CMC and GMP compliance requirements for new drug approval are ridiculously strict compared to the EMA, and they don't approve drugs under "exceptional circumstances". Also, they appear to have significantly changed the manufacturing process since 2014.


The particular facility where Scenesse is manufactured is primarily a development facility for medical polymer based technologies. Up until recently, the laboratory has been focused exclusively on the development of new medical technologies. Scenesse will be the first FDA approved drug to be commercially manufactured there. The transition to commercial manufacturing is still a work in progress, though Evonik has invested $50 million in the last 4 years to expand the capabilities of the Birmingham facility.

Long story short, they're still working out the kinks, which is causing delays. Unfortunately, we have no choice. They is literally no one else with the capabilities to commercially manufacture Scenesse.


EVERYTHING BELOW THIS POINT IS SPECULATION

This is unsubstantiated, but I heard that Clinuvel is no longer planning on using their long-time contract manufacturer for the API (active pharmaceutical ingredient). Since well before EMA approval, Lonza Ltd (since acquired by Polypeptide) has been the manufacturer of the afamelanotide peptide (API). Polypeptide has FDA and EMA approved peptide manufacturing facilities which supply Evonik with the API used to manufacture the implant to be commercially distributed in Europe.

Instead, for US commercial distribution, the peptide will also be manufactured by Evonik in the same Birmingham facility. There are some obvious long term benefits, but it also presents another obstacle to approval: the API is no longer being manufactured by an experienced company with a history of FDA compliance, instead, it's being manufactured in a facility that didn't even have the capability 2 years ago.

IF TRUE, I'm 50/50 that it was the cause of the 3 month extension. Manufacturing issues caused the RTF, and manufacturing issues were mentioned in the most recent newsletter. I truly hope that major amendment Clinuvel made to the NDA marks the end of the manufacturing issues and delays.

END SPECULATION

Attached File(s)
Attached File  a35820.pdf ( 66.6K ) Number of downloads: 86

 
  Forum: By Share Code

Johnny H
Posted on: Jun 26 2019, 07:47 PM


Group: Member
Posts: 672

QUOTE
"I know you are also here as **Johnny H** and you were here as the infamous grub **Reality Check (RC)** until you irreparably disgraced yourself.

Sad thing is you get plenty of “thanks” as the full of sh1t ramper JH"

I don't mind being called a "full of sh1t ramper", but to suggest that I'm Reality Check is a mean spirited cheap shot. You may as well just throw a drink in my face, steal my dog, and start dating my mom.

Regarding Palatin getting approval first: it was a logical outcome and not unexpected. The reasons why it happened are a confluence of financial, business, technical, and regulatory factors, including Palatin's decision to license the development and marketing of bremalanotide to an established pharmaceutical company with extensive experience in commercializing new drugs.

I will elaborate if you like, but regrettably, the following are not on my list of reasons:
-Regulatory hostility against afamelanotide
-Conspiracies that have persisted through several generations of the FDA workforce

On my list of reasons are:
-Clinuvel is learning the regulatory process as they go. It's slower and error prone, but much cheaper
-Manufacturing and CMC for new, novel technologies is more difficult and the additional challenges can delay approval. In this case, the contract manufacturer's facility has never produced an FDA approved drug. Scenesse will be the first, but it has a learning curve.

People, please do not thank me for this post; it makes Wally sad. I repeat: do not thank me for this post unless you want to make Wally sad.
  Forum: By Share Code

Johnny H
Posted on: Jun 23 2019, 06:27 AM


Group: Member
Posts: 672

"Now, as man has evolved this hormone has been repressed. We have replaced it with other cultural triggers"


Was I not supposed to be humping legs? Was that not allowed?
  Forum: By Share Code

Johnny H
Posted on: Jun 22 2019, 01:58 PM


Group: Member
Posts: 672

Nope. Zero shares In PTN.

My next moves are CAR-T therapies and a diabetes related treatment. That's years away, though.
  Forum: By Share Code

Johnny H
Posted on: Jun 22 2019, 12:46 PM


Group: Member
Posts: 672

I'm not incredibly pleased with some of Clinuvel's more recent management decisions, but they would never do what Palatin just did: a high five with a kick in the dick.

They already get a $60 million milestone payment from Amag for FDA approval. A $40 million dilution on the same day is just gratuitous. And this is for a company with a market cap of just above $270 million.
  Forum: By Share Code

Johnny H
Posted on: Jun 22 2019, 11:04 AM


Group: Member
Posts: 672

Seconded on your P.S.

I chose not to invest. My congratulations to the people who did. It's hard to handle that much winning.
  Forum: By Share Code

Johnny H
Posted on: Jun 22 2019, 08:45 AM


Group: Member
Posts: 672

I don't foresee much in sales at all.

Who is supposed to be prescribing it? The primary care physician? If a woman complains about lack of sexual desire to her PCP, 9 out of 10 doctors are going to go with a depression diagnosis and prescribe something else.

Amag/PTN is fighting an uphill battle here.


Although... it is good news for us. Not only is a melanocortin FDA approved now, but Amag/PTN did some of the same goalpost shifting that Clinuvel did in the clinical trials. Palatin shifted endpoints after phase 3 was completed. If the FDA was OK with that, they'll definitely be OK with Clinuvel doing it.
  Forum: By Share Code

Johnny H
Posted on: Jun 22 2019, 08:25 AM


Group: Member
Posts: 672

Now they have to market it.


Clinuvel already has a built-in market.
  Forum: By Share Code

Johnny H
Posted on: Jun 21 2019, 02:42 PM


Group: Member
Posts: 672

Is it time to pour out a 40 for my homies who sold too soon?
  Forum: By Share Code

Johnny H
Posted on: Jun 21 2019, 08:59 AM


Group: Member
Posts: 672

I'm curious how much of this expected volume will occur on the lit market.

At ASX 300 inclusion, there was a 500,000 share block trade through Centrepoint that wasn't reported until after close.


Would someone mind posting the book on open? I'm going to be watching like it's a spectator sport.
  Forum: By Share Code

Johnny H
Posted on: Jun 18 2019, 02:09 PM


Group: Member
Posts: 672

So you're saying that I should definitely quit my job right now?
  Forum: By Share Code

Johnny H
Posted on: Jun 18 2019, 09:35 AM


Group: Member
Posts: 672

Can somebody post the book at open?

I don't think I can stand to wait the extra 20 minutes.
  Forum: By Share Code

Johnny H
Posted on: Jun 18 2019, 07:00 AM


Group: Member
Posts: 672

Thank you.

And this statement is key:
"Between mid-July – late Sept anticipate a fall back in price with a low of..."

There will be a retracement. You can count on it.

The same thing that kept us from getting on the ASX 200 for so long also causes increased price movement: low relative liquidity. Institutional buying causes a jump in price on no news, which attracts short sellers.

I'm expecting to be happy, then disappointed, and then happy again. It's always a fun ride.
  Forum: By Share Code

Johnny H
Posted on: Jun 17 2019, 07:22 AM


Group: Member
Posts: 672

I've been looking at the institutional ownership of other companies who were recently added to the ASX 200. Nearmap, Hub24, etc etc. Their institutional ownership is MUCH higher than Clinuvel's.

The recent investor conferences plus Clinuvel's addition to the ASX 200 might attract more buyers than I initially expected. There is A LOT of room for the share price to increase before the FDA decision is announced.

I don't have access to historical data for institutional ownership for ASX listed companies, so this is by no means scientific or falsifiable.

But we do know that Clinuvel will be added to the 5 funds pictured below, plus any other funds mentioned previously. We have no way of knowing which international (US Based) funds will add Clinuvel to their portfolio, but it ranges from zero to a lot.

If anyone has access to the historical data and can make sense of it, I'm all ears. (not WAZ, he's earned his vacation)
Attached thumbnail(s)
Attached Image



 
  Forum: By Share Code

Johnny H
Posted on: Jun 15 2019, 11:37 AM


Group: Member
Posts: 672

In addition to the explicit ASX 200 index funds, I'm optimistic about some of the category funds (small cap, mid cap, international. etc) and the sector funds (medical and biotech).

When Clinuvel was added to the ASX 300, we were all closely watching the Vanguard ASX 300 fund, as it seemed to be the only game in town.

In addition, Vanguard picked up the stock in several other funds (at different times), including "Total International Stock Index Fund", "Developed Markets Index Fund", "FTSE All-World (excluding US) Small Cap Index Fund", and "Pacific Stock Index Fund".

While we can estimate the likely purchases of domestic (to Australia) ASX 200 index funds after the recent inclusion, there's no way of telling what the international funds might do. Whatever it is, it's definitely better now than it was before, so again, I'm optimistic.

I'm still incredibly irritated about the recent delay, but that post is for another time. I'm still trying to find the words.
  Forum: By Share Code

Johnny H
Posted on: Jun 15 2019, 05:09 AM


Group: Member
Posts: 672

Nearmap was added to the index effective after close on trading day 4/24. Close price that day was $3.28. One week later, the share price was $3.79. That's an increase of $.51, or 15.5%.

Clinuvel volume is lower and it is far less liquid, so any uptick in institutional buying is likely to cause a larger % increase in share price.


This assumes all other things being equal, which they aren't.




  Forum: By Share Code

Johnny H
Posted on: Jun 14 2019, 01:04 PM


Group: Member
Posts: 672

Ok... so the next step...

Which index funds track the S&P ASX 200?
  Forum: By Share Code

Johnny H
Posted on: Jun 14 2019, 10:10 AM


Group: Member
Posts: 672

How is the book looking this fine morning?
  Forum: By Share Code

Johnny H
Posted on: Jun 14 2019, 08:43 AM


Group: Member
Posts: 672

Waz rides home in the front seat. We’re stopping for ice cream on the way.
  Forum: By Share Code

Johnny H
Posted on: Jun 14 2019, 07:35 AM


Group: Member
Posts: 672

A few weeks ago, Morgan Stanley had Clinuvel's relative liquidity at 47%. The minimum for ASX 200 inclusion is 50%.

Our volume and daily turnover $ has gone WAY up since then.

The question is if it's enough to break 50% as of last Friday.
  Forum: By Share Code

Johnny H
Posted on: Jun 14 2019, 07:14 AM


Group: Member
Posts: 672

It's almost game time!

Is WAZ going to be a champion, or are we going to make him jog home behind the car?
  Forum: By Share Code

Johnny H
Posted on: Jun 13 2019, 12:55 PM


Group: Member
Posts: 672

Thanks!

If you have any leftover energy, can you also do my taxes?
  Forum: By Share Code

Johnny H
Posted on: Jun 11 2019, 10:20 AM


Group: Member
Posts: 672

Thanks.

I'm still 50/50 on the ASX 200 inclusion, but I bought today like it's definitely going to happen. Fear of missing out, I guess.
  Forum: By Share Code

Johnny H
Posted on: Jun 11 2019, 09:57 AM


Group: Member
Posts: 672

All righty...

What's the good word?

Book looking strong today?
  Forum: By Share Code

Johnny H
Posted on: Jun 11 2019, 07:48 AM


Group: Member
Posts: 672

You might end up having to order a new one if you pick an exact date.
  Forum: By Share Code

Johnny H
Posted on: Jun 8 2019, 07:37 AM


Group: Member
Posts: 672

Me again.

The order was less than half filled; I had to step away from my desk and couldn't adjust it. I have a pretty strict "no trading on the phone" rule.
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Jun 7 2019, 10:08 AM


Group: Member
Posts: 672

Interesting tidbit on page 5:
VWDA (Volume weighted daily average): 204,808. .42% OSC.

I've been a solid "no" on ASX200 inclusion. Now, I'm a solid "maybe".
  Forum: By Share Code

Johnny H
Posted on: Jun 7 2019, 08:02 AM


Group: Member
Posts: 672

When they say that they're not sure it's going to get a "clean label", does that necessarily mean they're going to get slapped with a black box warning?
  Forum: By Share Code

Johnny H
Posted on: Jun 6 2019, 07:23 AM


Group: Member
Posts: 672

If Vyleesi is rejected, I wouldn't read too much into it.

The considerations for the risk/benefit analysis are completely different from Scenesse.


Big picture: they're trying to market a drug for women to self-inject before sexual encounters. You can already find something like that in most big cities, and it's generally frowned upon.
  Forum: By Share Code

Johnny H
Posted on: Jun 5 2019, 11:02 AM


Group: Member
Posts: 672

The FDA wouldn't have a problem with it.

There's a select enforcement division within the SEC that has access to privileged FDA information.

If Clinuvel were an SEC reporting company, there would likely be some serious issues with a few of their more recent public statements in re: the FDA.
  Forum: By Share Code

Johnny H
Posted on: Jun 5 2019, 07:37 AM


Group: Member
Posts: 672

It's fair to assume that a NASDAQ listing is on hold for now, especially with the last press release. The SEC has back channel communications with the FDA. Not good for a company that's developing a habit of playing fast and loose with the truth,



  Forum: By Share Code

Johnny H
Posted on: Jun 4 2019, 09:10 AM


Group: Member
Posts: 672

Chemistry, Manufacturing, and Controls.


I posted the site inspection report for Evonik Birmingham a while back, and there were at least 4 issues identified during the initial pre-approval QA inspection.
  Forum: By Share Code

Johnny H
Posted on: Jun 4 2019, 08:34 AM


Group: Member
Posts: 672

I can tolerate delays. Sometimes, things are just out of your control.

However, what I will not tolerate is lying. It's an unacceptable way to do business.

We already know that Mcleish is leaving as soon as FDA approval comes. This is also Wolgen's final employment contract. That, coupled with the fact that Wolgen already lives in Singapore (great tax strategy, but a little premature, buddy) leaves me a little bit uneasy.

All of this information is going to be a matter of public record upon approval. The RTF, the major amendment to the NDA, it's all going to be in the Drug Master File. All of it.

What then? The people who lied are going to be long gone, and we're stuck holding the bag?


I haven't had the pleasure of interacting with Malcolm Bull, but some of you have, with positive results. I know he reads this forum, so my question is this:

Mr Bull, what are you going to do to restore investor trust, and when are you going to do it?
  Forum: By Share Code

Johnny H
Posted on: Jun 4 2019, 08:13 AM


Group: Member
Posts: 672

Bro, do you even "NASDAQ International"?
  Forum: By Share Code

Johnny H
Posted on: Jun 3 2019, 09:49 AM


Group: Member
Posts: 672

If I had to guess, it's CMC. Again.


They didn't have a proper sampling technique (surface testing only) for QA when they submitted the dossier. If they just finally got around to providing that info, the FDA doesn't have time to review it.


It's true that this is a frequent problem with contract manufacturers. It's also true that the Birmingham facility has never produced an FDA approved medicine before. But they had years to figure this out before filing. Years.


There's a newsletter coming out soon. I would hope that it adequately addresses this issue, transparently and honestly.
  Forum: By Share Code

Johnny H
Posted on: Jun 3 2019, 09:32 AM


Group: Member
Posts: 672

That's what I was alluding to. An extension doesn't just "happen". Clinuvel knows exactly why it happened, and they chose not to disclose why,
  Forum: By Share Code

Johnny H
Posted on: Jun 3 2019, 09:30 AM


Group: Member
Posts: 672

The last time we got really bad news (the RTF in September, you can call it whatever you want), the stock price went up more than 50% anyway due to ASX 300 inclusion.

Here we are starting down a possible ASX 200 inclusion (for reals this time!!!) with another bout of bad news.

I'm not going to even try to pretend that I can make sense of any of this.
  Forum: By Share Code

Johnny H
Posted on: Jun 3 2019, 09:17 AM


Group: Member
Posts: 672

They could have included quite a bit more information in that release. It's worth noting that they chose not to.
  Forum: By Share Code

Johnny H
Posted on: May 31 2019, 08:21 AM


Group: Member
Posts: 672

It's not illegal, but most brokers will have internal controls that trigger a warning or phone call if you try to do it. Some brokers might not even allow it at all.

If you're long on Clinuvel, shorting shares is functionally equivalent to selling shares that you already have. It has the same net effect. The difference, however, is that shorting shares incurs interest charges and subjects you to a potential margin call.

Any reputable broker is going to make sure to disclose this so that they don't get reamed by FINRA.

CLVLY is classified as a "hard to borrow" security. It's very expensive to short it. If you're long and you put in a short order, guess where your broker is going to borrow it from?

It looks really bad for a broker to loan a customer their own security at 20% interest when they could have just sold it.


Options are a different story, but unfortunately, there aren't any traded on the US market yet.




  Forum: By Share Code

Johnny H
Posted on: May 28 2019, 12:13 AM


Group: Member
Posts: 672

I believe you're referring to the situation with Alkermes (they received an RTF, and then a few weeks later, the FDA accepted the NDA for filing) as your example of the FDA playing 'fast and loose' with their policies. Although the situation was unusual, it was in accordance with FDA policy, and it shows that the FDA follows the law no matter what the circumstances are.

The timeline:
-The FDA made a determination to refuse to file Alkermes' NDA within 60 days of receiving it.

-The FDA issued a Refusal to File letter communicating the deficiencies in the NDA

-In response to the RTF, Alkermes requested an informal conference with the FDA regarding the NDA filing.

-Shortly after the informal conference, the FDA accepted Alkermes' original, uncorrected NDA for filing and issued a PDUFA date.


The Relevant FDA policy:
"If FDA refuses to file the NDA under paragraph (d) of this section, the applicant may request in writing within 30 days of the date of the Agency's notification an informal conference with the Agency about whether the Agency should file the NDA. If, following the informal conference, the applicant requests that FDA file the NDA (with or without amendments to correct the deficiencies), the Agency will file the NDA over protest under paragraph (a)(2) of this section, notify the applicant in writing, and review it as filed.... .....The applicant need not resubmit a copy of an NDA that is filed over protest. "
.

This particular situation was unusual because Alkermes invoked a rarely used policy. The FDA simply complied with that policy.

The reason that this policy is rarely used: it's incredibly stupid to do so. Filing under protest is an absolutely horrible idea. Alkermes is one of few stupid enough to have ever attempted it.

Spoiler alert:
Their strategy of forcing through a deficient application without making corrections?
Rejected! https://www.fiercebiotech.com/biotech/fda-r...-drug-alks-5461
Their strategy of lying to investors about the nature of their talks with the FDA?
Lawsuit! https://www.zlk.com/press/alks-lawsuit-alks-class-action

  Forum: By Share Code

Johnny H
Posted on: May 27 2019, 12:03 PM


Group: Member
Posts: 672

I think you're confusing CRL with RTF.

We are on our second submission, but first review cycle.

The first submission, June 2018, received a Refusal To File (RTF), and didn't make it past the validation period. This is a fact, not an opinion. It the only possible outcome under Federal law, and I have 2 pieces of direct evidence from independent sources that confirm it.

The NDA was re-submitted at the beginning of November, and was accepted for filing in January after the 60 day validation period, starting the PDUFA clock. We're now 2/3rds of the way through the first (and hopefully only) review cycle.

You are correct that receiving an RTF lowers our chances of receiving a CRL: important deficiencies identified in the RTF have already been corrected. It also allowed Clinuvel to address the problems 6 months earlier than if they had received a CRL.
  Forum: By Share Code

Johnny H
Posted on: May 27 2019, 09:21 AM


Group: Member
Posts: 672

From a consultant:

"A complete response letter (CRL) from the FDA delays a product’s entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them.

Researcher Theresa Allio, Ph.D., analyzed CRLs issued for 51 products approved by the FDA since 2009 and discovered striking underlying patterns:

Forty-seven percent of CRLs name deficiencies in CMC requirements. Imagine knowing which areas the FDA faults, then resolving these problems in advance.

The same percentage of CRLs list deficiencies related to product labeling. Here, too, knowledge is power — to resolve deficiencies before a CRL arrives.

Forty-five percent of CRLs include comments related to specific clinical deficiencies, many of which could be addressed during the drug development process to avoid unnecessary delays in an application’s review."
  Forum: By Share Code

Johnny H
Posted on: May 27 2019, 09:05 AM


Group: Member
Posts: 672

"to not approve Scenesse would be the utter definition of stupidity and an inquest into the decision making process would be well and truely justified"

Fortunately, disclosure of the FDA's decision making process is required by law. An NDA evaluation must either result in marketing approval or the FDA issuing a CRL. The CRL, or "Complete Response Letter", summarizes in great detail the reasons that approval was not granted and the changes necessary to gain approval. The CRL can run into the hundreds of pages and covers every aspect of the NDA.

For example, if FDA inspectors were to discover contaminated batches of Scenesse, approval SHOULD be denied, with a CRL describing the nature of the deficiency and the corrections required to gain approval. There's nothing stupid about it; it's a matter of safety.

If Scenesse isn't approved, the reasons will be spelled out.

One thing I can be certain of: Clinuvel won't get a CRL for something major like safety or efficacy, which would be a huge setback. Clinuvel expended tons of time and resources to make sure they got those right.

In the unlikely event that Clinuvel does get a CRL it will probably be something minor like labeling or CMC. Fortunately, these issues are Type 1 resubmissions, so the review cycle for the amended NDA is only 30 days instead of a full 6 months. It's a minor setback at worst. I figure a 2 month delay; 1 month for Clinuvel to make the changes, and a month for the FDA to review it.

Approval is imminent. The only question is when.
  Forum: By Share Code

Johnny H
Posted on: May 24 2019, 10:12 AM


Group: Member
Posts: 672

Thanks!

Peter Frampton's guitar is talking to me, and it's saying "MONEY".
  Forum: By Share Code

Johnny H
Posted on: May 24 2019, 10:03 AM


Group: Member
Posts: 672

Book, if someone wouldn't mind?

Thanks!
  Forum: By Share Code

Johnny H
Posted on: May 23 2019, 04:23 PM


Group: Member
Posts: 672

$8.5 million in turnover today. I hope the people at Standard and Poor appreciate that.
  Forum: By Share Code

Johnny H
Posted on: May 22 2019, 05:57 AM


Group: Member
Posts: 672

Just CLVLY. I'm not sure I'm even able to trade UR9, but I've never tried because of the double foreign currency exchange.
  Forum: By Share Code

Johnny H
Posted on: May 22 2019, 03:11 AM


Group: Member
Posts: 672

Yes, that's my order going through right now.
  Forum: By Share Code

Johnny H
Posted on: May 21 2019, 04:20 AM


Group: Member
Posts: 672

Great.

Did you see who was presenting?


I think we can safely write this one off.
  Forum: By Share Code

Johnny H
Posted on: May 20 2019, 08:28 AM


Group: Member
Posts: 672

IIRC, it's more downstream than anything else.

Even though the implant is a 60 day treatment, it's almost entirely released into the blood during the first 10 days.


Desert Rat would probably be the person to ask.
  Forum: By Share Code

Johnny H
Posted on: May 20 2019, 06:02 AM


Group: Member
Posts: 672

The issue with peptides is half-life. For MSH and derivatives, I've seen data indicating a half-life of anywhere between 15 and 80 minutes, depending on the data source.

That's why Scenesse is far less effective as an aqueous injectable. A single dose isn't in your system very long. In order to get the same effect as the implant, you have to inject small doses 10+ times a day.

One possible benefit to a topical is that it targets melanocytes without entering the bloodstream where it will quickly be metabolized. A single application of a topical that's stable at room temperature can deliver a sustained dosage to the area where it's applied.

It looks like Clinuvel is approaching this from both angles. Some of their patent filings indicate that one of their new molecules was designed for sustained half-life. I'm not sure about the other one, but if it's the topical, they might be developing it to have beneficial attributes other than extended half-life.

  Forum: By Share Code

Johnny H
Posted on: May 18 2019, 11:27 AM


Group: Member
Posts: 672

For your weekend reading pleasure.

Reading and digesting these is in my procrastination pile; if anyone else has the time, please share what you find.

The rocket science: Attached File  methodology_index_math_2.pdf ( 946.51K ) Number of downloads: 133


Float adjustment: Attached File  methodology_sp_float_adjustment_2.pdf ( 382.58K ) Number of downloads: 59
  Forum: By Share Code

Johnny H
Posted on: May 17 2019, 06:25 AM


Group: Member
Posts: 672

This is why Wolgen shouldn't be allowed to write newsletters. If you change the emphasis slightly:
"and in the coming weeks we may receive the awaited product labelling questions."

Or may not.


  Forum: By Share Code

Johnny H
Posted on: May 17 2019, 06:23 AM


Group: Member
Posts: 672

Wherever you go, you'll always be late?
  Forum: By Share Code

Johnny H
Posted on: May 17 2019, 04:58 AM


Group: Member
Posts: 672

Reading a newsletter written by Wolgen is a lot like watching an episode of LOST. You have to go through it several times to make sense of it, and even then, it's questionable.


We are now a month past the labeling communication deadline. One interpretation is that the FDA could be running behind schedule. However, another interpretation is that they could be ahead of schedule, and Clinuvel got the labeling portion of the NDA correct on the first try.

I point to the language in the PDUFA announcement in January:

"The FDA has advised that it does not intend to hold an advisory committee meeting during the final review of the SCENESSE® NDA, with proposed labelling and post-marketing requirements - if needed - to be communicated to CLINUVEL by 8 April 2019."

If Clinuvel got it right in the initial submission, there would be no need for further labeling communication. The FDA can accept it as is.

Note that this language appears TWICE in that newsletter.
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: May 15 2019, 10:16 AM


Group: Member
Posts: 672

Very long story short, Willem Blijdorp bought some shares in Clinuvel a while ago.
  Forum: By Share Code

Johnny H
Posted on: May 14 2019, 03:17 PM


Group: Member
Posts: 672

My apologies.

Check IMs.
  Forum: By Share Code

Johnny H
Posted on: May 14 2019, 02:24 PM


Group: Member
Posts: 672

In this context, we're talking about a removal and an addition due to an acquisition. It's not a rebalance, so it happens when it happens.

It's not what Seeva asked, but, I missed it a few times too and thought it worth mentioning.
  Forum: By Share Code

Johnny H
Posted on: May 14 2019, 10:39 AM


Group: Member
Posts: 672

Earlier today, I emailed Mr Stewart, the WSJ reporter listed in that article. He was kind enough to respond almost immediately, and gave me a very thoughtful and thorough reply. Unfortunately, he asked me not to publicly share his reply, as he is a reporter, and has not independently verified the information provided to him by Morgan Stanley, nor has anyone else at the Wall Street Journal.

Combined with what we already know and have previously discussed in this forum and my email exchange, I can safely conclude the following:

-Clinuvel is in fact the the highest ranking stock outside of the ASX 200. By both my calculations and MS's, they are above the 174 threshold for inclusion. (I calculated them at 171, which was not the same as MS's calculation)

-Relative Liquidity continues to be the sticking point. I couldn't come up with a reliable calculation myself. Too many assumptions. Morgan Stanley's analyst had a calculation that was just barely below the requirement. But again, this was not independently confirmed, and should not be taken as fact. Suffice to say that it's a close call, and the biggest (read: only) hurdle.

-S&P inclusion is not a strict algorithm. There is a human factor, and exceptions can and will be granted under discretion. Morgan Stanley seems to think that's important, as they provided public comment to a journalist on the matter.
  Forum: By Share Code

Johnny H
Posted on: May 11 2019, 11:29 AM


Group: Member
Posts: 672

It all depends on if they go for a co-listing, or if they redomicle in the United States. If it's a co-listing, the symbol can stay the same. 5 letter tickers ending in "Y" are ADRs (ie Volkswagen VWAGY).

The important issue here is the continuous disclosure and reporting requirements, which are far stricter in the US than other markets.

As a pink sheet OTC, Clinuvel is exempt from SEC reporting.

With a NASDAQ co-listing, they are not exempt. No more cryptic newsletters. The stuff that they've gotten away with in the past won't fly with the SEC.
  Forum: By Share Code

Johnny H
Posted on: May 8 2019, 02:19 PM


Group: Member
Posts: 672

no
  Forum: By Share Code

Johnny H
Posted on: May 8 2019, 11:43 AM


Group: Member
Posts: 672

Would love if this could wait until Monday.
  Forum: By Share Code

Johnny H
Posted on: May 8 2019, 09:41 AM


Group: Member
Posts: 672

It was the correct decision. I don't have control of my ADR shares; BNY does. They should have to report controlling interest.


One thing that jumps out at me: the amount of shares they're reporting seems low to me. Very low.

When I have more time, I'll look into it.

Here's hoping I won't have to.
  Forum: By Share Code

Johnny H
Posted on: May 8 2019, 09:03 AM


Group: Member
Posts: 672

Page 4, Note 1
"By an instrument of relief dated 29 April 2019"

Some sort of change in reporting requirements.
  Forum: By Share Code

Johnny H
Posted on: May 8 2019, 08:55 AM


Group: Member
Posts: 672

This statement is patently untrue.

Under the existing ADR agreement, Clinuvel, at its discretion, may provide written instructions to BNY authorizing the voting of deposited shares, and prescribing the manner in which to do so.

At no point during the agreement has Clinuvel ever done so. As such, ADR shares are non-voting.




Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: May 7 2019, 10:03 AM


Group: Member
Posts: 672

Ideally, yes.

But in all likelihood, based on the numbers I have in front of me now, it will probably be around the same number of shares. My sale today was taxable, and my sale on Thur/Fri will also be taxable. If I come back with the same number of shares, taxes paid in full, I'll consider it a huge victory.
  Forum: By Share Code

Johnny H
Posted on: May 7 2019, 08:47 AM


Group: Member
Posts: 672

It was me. Needed a half mil for an IPO share allocation. No lockup period, so I’ll buy back by Friday, Monday at the latest.
  Forum: By Share Code

Johnny H
Posted on: May 3 2019, 11:15 AM


Group: Member
Posts: 672

I haven't previously posted this because I didn't think it was relevant anymore, put PW's letter puts things in a new perspective.

"It is fair to state that chemistry, manufacturing and controls (CMC) has received the lion’s share of the attention thus far, not unexpectedly since the FDA attributes great significance to continuation of treatment even before a product reaches the market. Equally, issues such as GMP processes receive relatively more attention in the US than in the EU during the regulatory review stage.

Evonik Birmingham Laboratories was inspected in last August, and there were 4 observations by the FDA.

Based on PW's above statement, it sounds like they're still working out some manufacturing issues, and that may be responsible for the delay in labeling requirements.

I have attached FDA form 483 from the August inspection. For the perspective of the inspectors, the observations on the form are ordered from most to least important.

-Observation 1: Easily fixable. Set appropriate user permissions and audit trails

-Observation 2: Not an ongoing issue (although it did lead to a batch rejection, which is a potential "continuation of treatment" issue). Don't deviate from procedures in the future

-Observation 3: Easily fixable. Scenesse 16mg is a solid implant, and they were only surface testing it. Adjust laboratory controls to include testing to the interior of the implant.

-Observation 4: Preventative maintenance. This is easily fixable, but time consuming. Equipment failure is also a potential "continuation of treatment" issue, and could be responsible for the current delay.

So again, in my opinion, none of these are remotely serious enough for a CRL.
Attached thumbnail(s)
Attached Image

Attached Image


Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Apr 28 2019, 07:25 PM


Group: Member
Posts: 672

The thing that is absolutely stopping me: quality control.

Counterfeit is exactly that: counterfeit. There are plenty of companies on the internet selling Chinese made knock-off peptides for $3 per milligram with a claim of 99.9% purity.


To put that into perspective, one of the most reputable peptide manufactures in the United States manufactures NDP-MSH/afamelanotide and sells it for legitimate scientific research. Each batch of peptides is delivered with an audited QC summary sheet including:
-2 reverse phase HPLC profiles to verify purity
-mass spectrometry to verify molecular weight (performed and certified by an independent 3rd party)
-amino acid analysis to verify composition

They are the absolute best in the business, and despite all of their expertise, their batches of afamelanotide/NDP-MSH are only about 96% guaranteed purity.. And guess how much they charge for 10 milligrams of NDP-MSH/afamelanotide?

$630.

The websites selling the knock-offs are obviously lying about what they're selling. If they're lying about that, what else are they lying about? Are they selling rat poison? It's just not worth the risk.

Of course, I can think of an easy way for the FDA to eliminate that risk if they want to....






Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Apr 24 2019, 03:16 PM


Group: Member
Posts: 672

They changed up the website a little bit. It's here:
https://www.clinuvel.com/investors/news/announcements

As far as the "why did the price go down?!?!?", there were 150k shares shorted.

Count your eggs in July; until then it's a blood sport that no spectator can enjoy.
  Forum: By Share Code

Johnny H
Posted on: Apr 24 2019, 11:48 AM


Group: Member
Posts: 672

10 is a single order of magnitude, so that's the minimum.


Unless Stan is a liar.

Just kidding, Stan. Prove me wrong.
  Forum: By Share Code

Johnny H
Posted on: Apr 24 2019, 10:32 AM


Group: Member
Posts: 672

He reveals a lot of good news.

-Institutional and pension funds inquiring directly to the company (I guess they do answer their phone!)

-an expectation of an increase in institutional investors in the near future

and this statement

-"I am very pleased to state that nine key personnel have grown and remained at CLINUVEL longer than ten years"

Clinuvel is a tiny company. If that many key personnel have stuck around for a decade, they know something we don't know, and there are big things to follow.
  Forum: By Share Code

Johnny H
Posted on: Apr 24 2019, 09:39 AM


Group: Member
Posts: 672

New letter from the Chair.

"CLINUVEL will have all key ingredients to become a company of an order of magnitude larger than what it is now".

I'm gonna be honest here: I really like the sound of that. Really like it.
  Forum: By Share Code

Johnny H
Posted on: Apr 23 2019, 10:59 AM


Group: Member
Posts: 672

I really wish this were on NASDAQ so we could trade options. I'd lever up to the hilt on Clinuvel 6 month calls.

I looked into CFDs for US citizens. It's not going to happen. It's illegal on several levels. Bummer.
  Forum: By Share Code

Johnny H
Posted on: Apr 21 2019, 12:40 AM


Group: Member
Posts: 672

It's a good problem to have; everyone is paying on time.
  Forum: By Share Code

Johnny H
Posted on: Apr 20 2019, 09:48 AM


Group: Member
Posts: 672

The last time I looked into the Singapore operations (over a year ago), I think I concluded that the entire operation was centered around optimizing the efficacy of the New Molecules in the human body. I can't remember what led me to that conclusion, but I think it was a combination of the expenditures and some of the job postings that other people here found.


I wouldn't expect to see much new research out of Clinuvel yet for reasons already stated below.
  Forum: By Share Code

Johnny H
Posted on: Apr 19 2019, 10:06 AM


Group: Member
Posts: 672

Scratch that. Trading holiday.


  Forum: By Share Code

Johnny H
Posted on: Apr 19 2019, 07:35 AM


Group: Member
Posts: 672

The cross-border arbitrage mechanism for this stock is done on the Australian market though HSBC. They would have to remove shares from the ASX marketplace and hold them on deposit in order for ADRs to be issued on the US market. Look for that to happen at some point today.

To my knowledge, there is no ADR pre-release provision in Clinuvel's (then Epitan's) agreement with BNY Mellon, as it was not common practice at the time the agreement was signed, and the agreement has not been updated according to SEC filings.

(as an aside, in my opinion, ADR pre-releases are outright fraud, even if it is done in accordance with the law. It's theft. Period.)

We'll see.
  Forum: By Share Code

Johnny H
Posted on: Apr 18 2019, 10:12 AM


Group: Member
Posts: 672

More visibility for the company.

But for us retail shareholders, the benefits are a higher share price and better liquidity.


I'm less than 50/50 on a June inclusion if the volume stays where it's been. Doesn't really matter, though; July FDA decision right around the corner.


And.... if we get a true Nasdaq listing, ASX 200 won't matter at all; we'll have unfettered access to the largest capital market in the world.
  Forum: By Share Code

Johnny H
Posted on: Apr 18 2019, 07:56 AM


Group: Member
Posts: 672

It couldn't be anything other than liquidity.

A big chunk of CUVs shares are tied up in the ADR, which is a pink sheet. Almost every single CLVLY transaction is through a market maker, so the already abysmal trading volume is actually half of what it appears to be. S&P almost certainly has this data and takes it into account.


HSBC is the local Australian custodian for BNY Mellon's depository shares. (See below)

That's almost 25% of total CUV shares (not even float adjusted) just sitting there doing nothing.

Of course, this will be a non-issue with a true NASDAQ listing.







Attached thumbnail(s)
Attached Image



 
  Forum: By Share Code

Johnny H
Posted on: Apr 17 2019, 11:13 AM


Group: Member
Posts: 672

$4000 for the report.


I thought we agreed that you were buying it. You're not going back on your word, are you?
  Forum: By Share Code

Johnny H
Posted on: Apr 17 2019, 09:22 AM


Group: Member
Posts: 672

http://industrynewstoday.com/68971/global-...llinckrodt-plc/

What are the chances that this actually has information about CUV-9900 and VLRX-001?

I'm going to go with zero. 0% chance.
  Forum: By Share Code

Johnny H
Posted on: Apr 16 2019, 09:13 AM


Group: Member
Posts: 672

We have some persistent liquidity issues relative to other ASX 200 candidates. It all depends on how they calculate the float.

  Forum: By Share Code

Johnny H
Posted on: Apr 15 2019, 09:29 AM


Group: Member
Posts: 672

Over 50% of last Wednesday and 70% of last Thursday's volume was short action. Looks like we're approaching another high in short interest.

Last Friday's data won't be available for a few more hours. I'm curious to see if there was more of the same.

https://www.shortman.com.au/stock?q=cuv

Somebody's balls are bigger than their brains. Doing this again is incredibly risky.

Vanguard added a bunch of CUV shares to some of their US based mutual funds last month (namely Vanguard Total International Stock Index Fund, 250k shares; Vanguard Developed Markets Index Fund, 100k shares; and Vanguard FTSE All-World ex-US Small Cap Index Fund, 50k shares).

When Vanguard adds 400k shares of CUV, the price goes through the roof. I'd be pleased to see it happen again.
  Forum: By Share Code

Johnny H
Posted on: Apr 14 2019, 09:02 AM


Group: Member
Posts: 672

Clinuvel is ahead of 37 companies that are currently listed on the ASX 200.

Even with the rules meant to prevent frequent turnover, there are a few that are so low that they will certainly be removed.
  Forum: By Share Code

Johnny H
Posted on: Apr 13 2019, 04:58 AM


Group: Member
Posts: 672

Update on my ASX 200 rebalance tracking.
All calculations include CUV, CLVLY, CLVLF, and UR9


For March rebalance calculations, we had:
Average share price of $19.64
Average 6 Month Volume Weighted Market Cap of $961 Million
Average 6 Month Daily Volume of 91,268
Median 6 Month daily volume of 71,984

This fell short of qualifying for inclusion in the ASX 200.

Currently, the data for the June rebalance has:
Average share price of $24.04
Average Volume Weighted Market Cap of $1.177 Billion
Average 6 Month Daily Volume of 96,265
Median 6 Month daily volume of 73,364

Projected data at close of June rebalance period (assuming continuing trends and constant share price):
Average share price of $25.50
Average 6 Month Volume Weighted Market Cap of $1.248 Billion
Average Daily Volume of 104,500
Median 6 Month daily volume of 78,000* (difficult to project median)

If the share prices goes way above $26 before June, expect the projected numbers to jump as well.

If we aren't included in June, I give up, and I have no idea what the hell is going on.

Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Apr 12 2019, 09:41 AM


Group: Member
Posts: 672

I've gotten those calls from Etrade and Vanguard a few times.

They're "checking in on you" because they want to make sure you keep those shares in their margin account where they can make money on them.

Last time I got the call, I mentioned I was considering transferring the shares to a new broker. We both knew I was bluffing, but I got 100 commission-free trades out of it.
  Forum: By Share Code

Johnny H
Posted on: Apr 10 2019, 07:50 AM


Group: Member
Posts: 672

The meeting is among the FDA review committee members working on different parts of the NDA, who provide feedback on the proposed labeling. The meeting is to determine if the labeling submitted with the NDA is acceptable, or if it needs to be revised. Clinuvel does not participate in the meeting. The results of the meeting are communicated to Clinuvel by the proposed labeling deadline.

At this point, Clinuvel should know if they are required to submit a revised draft to meet the labeling requirements.

I doubt they'd make any sort of public statement, especially if they've been notified that they are required to submit a labeling revision.

  Forum: By Share Code

Johnny H
Posted on: Apr 9 2019, 09:33 AM


Group: Member
Posts: 672

The NDA review is confidential until approval. The FDA can't publicly comment on the labeling deadline, and Clinuvel probably won't comment beyond acknowledging when they received the communications from the FDA.

FWIW, We're on Step 13 now.

Note the language in Step 16: "If approval is imminent with insufficient time to submit a formal amendment,"

Awesome.

Attached thumbnail(s)
Attached Image

Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Apr 8 2019, 02:48 AM


Group: Member
Posts: 672

The FDA site inspection database is finally updated to include the inspection of Evonik Birmingham Labs (contract manufacturer of the implant) as part of Clinuvel's pre-NDA submission.

According to the FDA records branch chief whom I spoke to on the phone, the public inspection database is updated monthly for routine inspections. However, for inspections that are part of a pre-clinical/NDA, the inspection records for the site are delayed by at least 6 months to protect commercial secrets. I'm not sure exactly when this record was made available in the public database, but it was not there when I searched in mid-March.

According to the Form 483 I have for this inspection, there are 4 observations that led to a status of "VAI". These manufacturing issues have been discussed at length here, and were corrected by Clinuvel and Evonik prior to the acceptance of the NDA for priority review. This was the first FDA GMP inspection of the Birmingham location; observations are somewhat expected in this scenario.

I still don't see any recent site inspections for Polypeptide, the manufacturer of the API in Scenesse, but I have it narrowed down to 2-3 possible locations. (Polypeptide is the largest peptide manufacturer in the world, and produces over 1/3 of global peptide APIs. Their facilities have been GMP certified dozens of times by the FDA. Passing the pre-approval inspection for Scenesse should be trivial).


Overall, this confirms a portion of the reasons Clinuvel has given for the filing delay (namely, FDA requests for additional manufacturing data).

Here's hoping everything else is on track!

Attached thumbnail(s)
Attached Image

Attached Image



 
  Forum: By Share Code

Johnny H
Posted on: Mar 29 2019, 11:57 AM


Group: Member
Posts: 672

Thanks.

From the info you provided, it looks like our big seller is unlikely to be Fidelity. Brown Bros is the custodian for almost all of their remaining shares.

Lagoda? Maybe. They have a whole bunch of custodians.
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Mar 27 2019, 09:21 AM


Group: Member
Posts: 672

Well played. Let's wait a day to post the video.
  Forum: By Share Code

Johnny H
Posted on: Mar 22 2019, 08:29 AM


Group: Member
Posts: 672

It's also a pension fund. They need the money for pension payments.

Especially Fidelity Japan. I can only imagine what kind of financial pressure there is on that retirement system.
  Forum: By Share Code

Johnny H
Posted on: Mar 22 2019, 06:11 AM


Group: Member
Posts: 672

This will be Jazz's second major drug. And it's a stimulant, so yes, it has almost unlimited possibilities.

The only explanation I can think of is that they had their PDUFA date extended by 3 months back in December, so approval was already priced into the stock.
  Forum: By Share Code

Johnny H
Posted on: Mar 22 2019, 04:31 AM


Group: Member
Posts: 672

Meanwhile, Jazz's new drug was approved yesterday, and their stock price is no higher than it was a week ago. Bizarre.
  Forum: By Share Code

Johnny H
Posted on: Mar 21 2019, 10:07 AM


Group: Member
Posts: 672

Shouldn't there be an ASX price query after a 20% drop?
  Forum: By Share Code

Johnny H
Posted on: Mar 21 2019, 07:14 AM


Group: Member
Posts: 672

They obviously packed up the carnival and fled town in the middle of the night. The facebook post is just a diversion.
  Forum: By Share Code

Johnny H
Posted on: Mar 21 2019, 12:58 AM


Group: Member
Posts: 672

Replace "mashed potatoes" with "blender" and you have my agreement.
  Forum: By Share Code

Johnny H
Posted on: Mar 20 2019, 02:15 PM


Group: Member
Posts: 672

Tonight was a nice attitude check for me. Sometimes I need it.

I've been treating this like a spectator sport where I always win. No more "WTF only 2% gain tonight???



  Forum: By Share Code

Johnny H
Posted on: Mar 20 2019, 11:45 AM


Group: Member
Posts: 672

I just told my wife "Hey, remember that day I lost a million dollars? I remember it like it was tomorrow!"

And now I have to tell her I was just kidding.
  Forum: By Share Code

Johnny H
Posted on: Mar 20 2019, 11:28 AM


Group: Member
Posts: 672

This has to be an accidental error. Somebody had an old order on 60 day execution, and... whoops
  Forum: By Share Code

Johnny H
Posted on: Mar 20 2019, 11:21 AM


Group: Member
Posts: 672

This is certainly going to result in an ASX price query, right?


Would somebody mind posting the depth? The more data, the better.
  Forum: By Share Code

Johnny H
Posted on: Mar 20 2019, 09:49 AM


Group: Member
Posts: 672

I like the sound of that.


Except for "In the coming weeks". I hate the sound of that.
  Forum: By Share Code

Johnny H
Posted on: Mar 20 2019, 07:26 AM


Group: Member
Posts: 672

That took me down a rabbit hole.

On the calendar, it shows that Jazz Pharma has a new drug for narcolepsy. The PDUFA date is tomorrow. It has an orphan drug designation. How is that even possible? There are several existing treatments for narcolepsy, including a drug that they already sell (Xyrem).
  Forum: By Share Code

Johnny H
Posted on: Mar 20 2019, 03:11 AM


Group: Member
Posts: 672

I ran the PDF through a crappy online translator. It looks like they are allowing the importation of Scenesse, but requiring the leaflet to be printed in Italian.
Attached File(s)
Attached File  determina_SCENESSE.it.en.pdf ( 1.25MB ) Number of downloads: 84

 
  Forum: By Share Code

Johnny H
Posted on: Mar 19 2019, 09:53 AM


Group: Member
Posts: 672

Question on the Morningstar comment you made the other day:

I have a premium subscription, and when I click on the "Ownership" tab for Clinuvel, it says that ownership data is restricted.

Am I looking in the right place?

Thanks in advance.
  Forum: By Share Code

Johnny H
Posted on: Mar 19 2019, 09:21 AM


Group: Member
Posts: 672

CLVLY hit $21 USD today too.
  Forum: By Share Code

Johnny H
Posted on: Mar 18 2019, 12:42 PM


Group: Member
Posts: 672

Thank you to everyone for your replies. It's Saint Paddy's Day, so I have zero chance of forming an intelligent thought right now, but, I did just notice that the reported gross shorts for CUV on Friday was 125,589 shares. Wow.
  Forum: By Share Code

Johnny H
Posted on: Mar 18 2019, 08:48 AM


Group: Member
Posts: 672

Would somebody mind posting the book shortly after open? I'm really curious what's going on after last Friday.

Should be an interesting week.
  Forum: By Share Code

Johnny H
Posted on: Mar 17 2019, 11:38 AM


Group: Member
Posts: 672

Along those lines, Wolgen is Hank Scorpio.
  Forum: By Share Code

Johnny H
Posted on: Mar 16 2019, 09:49 AM


Group: Member
Posts: 672

I would guess that the sell order has been on Centrepoint for several months.

As soon as a buy order came in, it matched and executed. Fidelity would have sold sooner, but they didn't have the necessary buy pressure, and had to slow bleed on the open market.

Almost every trading day this week, the price has gone down a bit before it recovers. It's probably Fidelity (or other seller) testing the waters to see how much they can unload without driving the price down too much.


It would be my personal preference that we just get this over with. The 400k share transaction is a step in the right direction. If someone wants to exit.... the sooner, the better. I don't like playing the same game 200 times in a row.




  Forum: By Share Code

Johnny H
Posted on: Mar 15 2019, 08:36 AM


Group: Member
Posts: 672

NICE Update

QUOTE
15 March 2019

CLINUVEL PHARMACEUTICALS LTD announced that it had met with the Highly Specialised Technology (HST) Committee of the English National Institute of Health and Care Excellence (NICE) in Manchester on 14 March (Greenwich Mean Time) as part of the ongoing evaluation of CLINUVEL’s drug SCENESSE® (afamelanotide 16mg).1 This constituted the third Committee meeting since 2017. The discussions centred around the grounds of appeal upheld by the NICE Appeal Panel in October 2018 and around the possibility of a Managed Access Agreement for SCENESSE® for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
The next steps will be for the HST Committee to issue a new Final Evaluation Document (FED). Timelines have not been disclosed.


Not one of their most informative press releases, but whatever.

NICE sucks.
  Forum: By Share Code

Johnny H
Posted on: Mar 14 2019, 01:53 PM


Group: Member
Posts: 672

It's a great problem to have.

It bothers me to not be able to explain the world around be as I understand it, but this is one of those times where I'm going to have to let it go.

There are people with more resources than me who obviously know something that I don't. The share price is going up. I'm just going to take the win.


As a result of the FDA filing delays, I did a little bit of independent research on my own to try and figure out what was going on. I don't work in finance, and I'm not a professional investor. I was shocked at how easy it was to get the information I was looking for.

I can only imagine how easy it is for a boutique asset management firm with bloomberg terminals and a research staff that is trained in the art of dumpster diving.


I don't know what's going on, but I'm very grateful that it's happening.
  Forum: By Share Code

Johnny H
Posted on: Mar 14 2019, 11:18 AM


Group: Member
Posts: 672

It's really bizarre.
Another 18,433 shorts yesterday.

Lagoda and Fidelity are long gone. The shorts are the only thing keeping the lid on the share price, and it's not going to end well for them.
  Forum: By Share Code

Johnny H
Posted on: Mar 14 2019, 07:51 AM


Group: Member
Posts: 672

Honestly, if Clinuvel suddenly decided not to show up to the meeting with NICE, I think I'd support the decision.

It's a farce, and they're only pretending to reconsider. The entire point of the excercise is to drown Clinuvel in paperwork and bureaucracy while maintaining the illusion that they care about patient's rights. I'm curious to see what the evaluation committee has to say this time, but it's almost certainly more of the same.



I wrote off UK sales a long time ago. Every time Clinuvel engages them and appeals, it weakens their position with other countries. (the Norway correspondence, in part, looks like it was copied and pasted directly from the NICE decision. Bad precedent.)


I think that it's probably time to say no to NICE, and do it on Clinuvel's terms.
  Forum: By Share Code

Johnny H
Posted on: Mar 14 2019, 07:41 AM


Group: Member
Posts: 672

Yep.

A.C.N. 108 768 896 Pty Ltd. is the employee share scheme trust. It includes Wolgen's shares.
  Forum: By Share Code

Johnny H
Posted on: Mar 13 2019, 04:47 AM


Group: Member
Posts: 672

After 714 days in the hospital, our buddy Skylar is finally coming home.
https://www.gofundme.com/bringingskylerhome...-supporters-v5b

  Forum: By Share Code

Johnny H
Posted on: Mar 12 2019, 01:59 PM


Group: Member
Posts: 672

CA is 13.3%, on top of federal LTCGT and NIIT.

I'm actually quite curious about what other people here are doing in re: taxes. We have another couple of months to discuss.

I've held Clinuvel for quite a long time; if you average the gains over 15 years, it doesn't seem like that much money. But, taxation law treats it like the money just fell out of the sky. There are short term gains, and then there are long term gains. That's it. No "I held on for 15 years of agony when I could have put my money to better use".

And, CA is second only to NY in tracking down former residents and claiming that "they never really left". The case law is actually quite fascinating. One case came down to where a taxpayer's dog lived.


Without violating privacy, what are your tax strategies, Sharecafe?
  Forum: By Share Code

Johnny H
Posted on: Mar 12 2019, 01:09 PM


Group: Member
Posts: 672

Palm Desert, CA.

2 hours from home. I'm stuck in LA for the foreseeable future.
  Forum: By Share Code

Johnny H
Posted on: Mar 12 2019, 11:45 AM


Group: Member
Posts: 672

Congrats!

I hope you got a discount. There appears to be snow just sitting on the ground!


I have a low ball offer in somewhere a bit warmer.

Less than a one in ten shot of getting it for what I'm willing to pay, but a man can dream. There's a half acre of lawn behind the pool for my kids to play. Too bad I can't move permanently for several years.

Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Mar 12 2019, 10:35 AM


Group: Member
Posts: 672

Another 16,900 shorts yesterday.


You reap what you sow.
  Forum: By Share Code

Johnny H
Posted on: Mar 8 2019, 08:24 AM


Group: Member
Posts: 672

It has to be a liquidity issue.

I ran the numbers on the 6 month period used to calculate the rebalance. They look fine to me.



As far as float, Ender's shares are excluded, Bjildorp's shares are excluded, and so is everything in the trust for Wolgen et al.

Also, the liquidity for the ADR sucks, and that's what? 30% of the shares?
Attached thumbnail(s)
Attached Image



 
  Forum: By Share Code

Johnny H
Posted on: Mar 8 2019, 05:44 AM


Group: Member
Posts: 672

The update for March 2019 for ASX200 and 300 is up on https://www.asx200list.com and https://www.asx300list.com.

As of March 1st, Clinuvel is #166 on ASX 300, with a weight of .07.

Due to slightly different listing requirements, it would be #161 on ASX 200.

  Forum: By Share Code

Johnny H
Posted on: Mar 6 2019, 10:32 AM


Group: Member
Posts: 672

FDA chief Scott Gottlieb resigns
https://thehill.com/policy/healthcare/43270...resigns-reports

"In a note to FDA staff, Gottlieb said he was leaving to spend more time with his family."

  Forum: By Share Code

Johnny H
Posted on: Mar 4 2019, 08:55 AM


Group: Member
Posts: 672

I'm a bit nervous. We're cutting it very close on average market cap for the prior 6 months. The average is calculated from trading data for the 6 month period beginning Monday, August 27th 2018 and ending Friday, February 22nd 2019. This date range is very unfavorable for us on both ends.

The first day was the share price low for the period, $12, which drags down the average. We're also missing out on the most recent jump in share price after Feb 22: a full week of trading in the $25 range that could have bumped up the average.

We could end up missing the March rebalance by one week. One. Week. If so, we're definitely guaranteed for the June rebalance.


if you look at the ASX 300 Ex- ASX 200 Index (all ASX 300 constituents who are not also ASX 200 constituents), Clinuvel is #1 by index weight.

https://au.spindices.com/indices/equity/sp-...x-200-index-aud
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Mar 2 2019, 04:52 PM


Group: Member
Posts: 672

It could be a metaphor:

--Earth's magnetosphere is photoprotection.

--The upper atmosphere is protoporphyrin IX.

--Solar particles can penetrate earth's magnetosphere through open field lines at high latitudes and ionize atmospheric gases, much like protoporphyrin IX is ionized by Ultraviolet/400nm light in unprotected skin.

--Ionized atmospheric gases emit beautiful lights in the sky. UV ionized Protoporphyrin IX emits free radicals that damage red blood cells and cause injury to the skin.


OK, the last part of the metaphor doesn't make sense. Unless.... it's part of new viral marketing billboard campaign featuring Frilly saying things like:

"Earth's protective layer has holes. Coming soon, a personal protective layer that doesn't. Talk to your doctor to see if Scenesse is right for you."

"Scenesse, the only systemic long term photoprotection that has you covered 24 hours a day, even when the sky is glowing at midnight."



Seriously though, a "Clinuvel News" release on the Northern Lights, cribbed from wikipedia and stretched out into a 4 piece series? Their fascinating and topical media campaign must be reaching an audience of dozens by now! Between this and Giles Delaney, I don't know why they bother. It almost feels like I'm reading the articles in an in-flight magazine.

They need to stop spending money on this; not only is it wasteful, it comes across as very amateurish.



  Forum: By Share Code

Johnny H
Posted on: Mar 1 2019, 12:16 PM


Group: Member
Posts: 672

It's the first Friday in March! One week from today, the rebalance (if any) will be announced, and will take place at market close 2 weeks from today, to be effective the following Monday.

I've highlighted the trading patterns from CUV's addition to the ASX 300 in September, emphasizing the difference between the share price at market close prior to the action, and the closing share price after 3 full trading days.

Please note that there are 2 weeks notice given for the rebalance in September, while there is 1 week of notice given for the rebalance in March.

And yes, this is in no way scientific. The points I picked are somewhat arbitrary, and I'm not claiming evidence of causality.

Still, a man can dream. Here's hoping for a 50% bump!

Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Feb 28 2019, 12:07 PM


Group: Member
Posts: 672

So.... you're saying Fiji AND Tahiti?
  Forum: By Share Code

Johnny H
Posted on: Feb 28 2019, 11:40 AM


Group: Member
Posts: 672

My man....Verhaven... what's going on here?

  Forum: By Share Code

Johnny H
Posted on: Feb 28 2019, 04:21 AM


Group: Member
Posts: 672

Less than 6000 shorts on Wednesday on a volume of 263,000 and a price gain of $1.06:

CUV CLINUVEL PHARMACEUTICALS LIMITED FPO 5,956 47,857,986 .01


Somebody is taking some pain right now.


  Forum: By Share Code

Johnny H
Posted on: Feb 27 2019, 03:24 PM


Group: Member
Posts: 672

That's the word I'm looking for. Intriguing.

Most of the share price action in the last 2 years is pretty easily explainable, especially in hindsight.

This? It's something new, and I have no idea what's happening. 2 weeks from now, it would have fit neatly into my understanding of things.

Looks like we're in the big leagues now.

FWIW, I'm quite pleased. Also, Tahiti is better than Fiji.
  Forum: By Share Code

Johnny H
Posted on: Feb 27 2019, 02:13 PM


Group: Member
Posts: 672

SPOILER ALERT!
I'm on a 20+ minute delay!

As an aside, Clinuvel's website provides better data than asx.com.au, and with slightly less delay. It aggregates the volume of ASX and CHI-X: https://www.clinuvel.com/investors/share-prices

Over 226k in volume and $5.6 million in turnover so far today. But, again, 20 minute delay.
  Forum: By Share Code

Johnny H
Posted on: Feb 27 2019, 10:52 AM


Group: Member
Posts: 672

How about somewhere with fresh fruit? The buffet could get pretty boring if it only has frozen seeds and whale meat.
  Forum: By Share Code

Johnny H
Posted on: Feb 27 2019, 10:20 AM


Group: Member
Posts: 672

"on a tropical beach somewhere"

I vote for the Northern Hemisphere.
  Forum: By Share Code

Johnny H
Posted on: Feb 27 2019, 04:03 AM


Group: Member
Posts: 672

Via the performance plan, wasn't Wolgen entitled to a big chunk of shares upon FDA acceptance for filing?

He still hasn't claimed them. Maybe he's being a gentleman and waiting until approval.

  Forum: By Share Code

Johnny H
Posted on: Feb 26 2019, 10:53 AM


Group: Member
Posts: 672

That's definitely it.

Thanks.
  Forum: By Share Code

Johnny H
Posted on: Feb 26 2019, 10:15 AM


Group: Member
Posts: 672

Is there a problem with the ASX data stream? It's showing a crossed market in the middle of trading hours.
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Johnny H
Posted on: Feb 26 2019, 09:34 AM


Group: Member
Posts: 672

I was wondering the same thing.

Are the S&P calculations proprietary?

I'm not clear on how the 6 month average for market cap is calculated. If it's volume weighted, the odds are more in our favor, as we've had high volumes and high prices lately, which should drive up the average.
  Forum: By Share Code

Johnny H
Posted on: Feb 25 2019, 09:10 AM


Group: Member
Posts: 672

It's a penny stock. The total value of the daily turnover is far less than Clinuvel's.

A $100K investment in CLVLY will get you 5,970 shares.

A $100K investment in PTN will get you 117,647 shares.
  Forum: By Share Code

Johnny H
Posted on: Feb 19 2019, 03:28 AM


Group: Member
Posts: 672

New article up by Giles Delaney*
https://www.clinuvel.com/social-media/subq/...-drug-companies


*It's about time for Clinuvel to stop pretending that this is a real person.


  Forum: By Share Code

Johnny H
Posted on: Feb 19 2019, 03:10 AM


Group: Member
Posts: 672

Same reaction.

Highest close price ever? Meh.
  Forum: By Share Code

4 Pages (Click to Jump) V   1 2 3 4 >

Cant find what you are looking for? Show all active topics from the last 3 months


New Posts  New Replies
No New Posts  No New Replies
Hot topic  Hot Topic (New)
No new  Hot Topic (No New)



TERMS OF USE  -  CONTACT ADMIN  -  ADVERTISING