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CUV, CLINUVEL PHARMACEUTICALS LIMITED
NewToCli
post Posted: Today, 06:12 PM
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In Reply To: Johnny H's post @ Today, 03:38 PM

I assume PW also knows those deadlines so why the heck he is writing about that possibility in the newsletter if it is not any possibility at all due to the timeline?


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Johnny H
post Posted: Today, 03:38 PM
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In Reply To: macgyver's post @ Today, 11:12 AM

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



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Clinuvel until my bowels release for the last time.

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macgyver
post Posted: Today, 11:12 AM
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In Reply To: seeva222's post @ Yesterday, 10:54 PM

I'm assuming if we don't see an announcement from CUV come Monday or Tuesday then we're in the clear regards the AdCom.

 
sharelooker
post Posted: Today, 12:22 AM
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According to the conference program, CUV will host two symposia on wednesday and thursday! Hopefully, we'll get a nice presentation next week.

https://docs.wixstatic.com/ugd/09d8d3_516b4...71f458ce052.pdf



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seeva222
post Posted: Yesterday, 10:54 PM
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In Reply To: Johnny H's post @ Aug 22 2019, 02:48 AM

So I’m guessing they’re not working in the weekend.

 
johnnytech
post Posted: Yesterday, 10:14 AM
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In Reply To: Johnny H's post @ Yesterday, 07:44 AM

I would think if BNY Mellon was doing arbitrage and transferring shares, it wouldn't show up on retail lists. That shorting is a bit of a curiosity though at this stage. Watch that closely, if there are any news leaks, more likely to be amongst Americans with FDA insider ties, and they are going to go to CLVLY or CLVLF. Hopefully it's just regular retail shorting.

 


Johnny H
post Posted: Yesterday, 07:44 AM
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I'm not sure how this is even possible, but equity short interest in CLVLF has skyrocketed above 200,000 shares, which is over 3 months' worth of average trading volume. Maybe the shares were borrowed for cross-border arbitrage or ADR conversion?
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Clinuvel until my bowels release for the last time.
 
seeva222
post Posted: Yesterday, 12:28 AM
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We have entered the 45 day window with almost 6% outstanding shorts and less overall liquidity due to the ASX inclusion. Dividend announcement and labeling coming in the next few weeks and traders will re-enter the market after the summer doldrums.

]https://boards.sharecafe.com.au/index.php?act=attach&type=post&id=51690


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Johnny H
post Posted: Aug 23 2019, 08:05 PM
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In Reply To: LevelHeaded2000's post @ Aug 23 2019, 05:51 PM

The ADR administrator fee is the lesser of:

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

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

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

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

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










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Clinuvel until my bowels release for the last time.

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Johnny H
post Posted: Aug 23 2019, 06:02 PM
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In Reply To: sharelooker's post @ Aug 23 2019, 04:13 PM

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

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

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

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



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

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

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

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

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

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


Thanks for the data points!










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Clinuvel until my bowels release for the last time.

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