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CUV, CLINUVEL PHARMACEUTICALS LIMITED
ajshare
post Posted: Jun 24 2018, 03:36 PM
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In Reply To: seeva222's post @ Jun 24 2018, 07:07 AM

Okay. My prediction is that we have priority review. My theory as below:

1. Shortly after the 14th May update the NDA or efficacy supplement was submitted - if it was done before it will be telling a blatant lie to the market. Although there was no need for this update CUV wanted to postpone the 20th May announcement date for new product launch, which was not ready.

2. 1st June performance rights to the management was for condition E, which although met earlier was promised to the management only after NDA is submitted as the timing of it was very odd. This also resulted in signalling to the people in know how that the NDA is submitted. Share price dropped on ASX by selling few thousand shares to create a tree shake and over 300K shares bought in Europe market and ever since. The same thing happened few weeks before EMA authorisation and the share price collapsed from $4.75 on 15/9/2014 to $2.38 on 13/10/2014. The trading halt came on 24/10/2014 and EMA authorisation announced on 27/10/2014.

3. FDA makes a priority review decision within 14 days after the NDA submitted and if a priority review is granted everything is expedited as compared to standard review. (Reference as below from Review Designation Policy: Priority (P) and Standard (S)

RESPONSIBILITIES AND PROCEDURES
 The White Oak Document Room (DR1) is responsible for:
 Attaching the User Fee Validation Form to each application, when applicable.
 The Review Team is responsible for:
 Recommending a review designation to the division director for each NDA,
BLA, and efficacy supplement within 14 days. The recommendation is made
only if the application is to be filed.
 Identifying, within 14 days of receipt of an original NDA; original BLA; or
efficacy supplement, whether the application may qualify for a priority review
designation. If an application is expected to qualify for a priority review
designation, the filing meeting will be scheduled to occur by Day 30, instead
of by Day 45 (the filing meeting date for standard reviews).



MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 6020.3 Rev. 2
determination of the review designation and timeline for the first review cycle
will be determined by the division director at the filing meeting.6
 The Division Director is responsible for:
 Determining final review designation for each NDA, BLA, or efficacy
supplement no later than the filing meeting if the application is to be filed.
The division director will consider the recommendations of the review team
members.
 Communicating the final review designation to the regulatory project
manager (RPM).


4. As Clinuvel is under expedited program due to Fast Track and rolling review and now priority review, RPM is making it happen a bit earlier(still within 60days).

REST we will find out tomorrow or Tuesday.

I am sure that JULY will have many pending announcements coming through including NME - novel molecules CUV9900 and VLRX001, ENFANCE, non-prescriptive products and much more.


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macgyver
post Posted: Jun 24 2018, 03:17 PM
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In Reply To: Johnny H's post @ Jun 24 2018, 01:14 PM

Good news.

 
Frogster
post Posted: Jun 24 2018, 02:13 PM
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In Reply To: ajshare's post @ Jun 24 2018, 01:10 PM

Remember that 924,974 number is the total of performance rights that he holds. They convert to shares on a variety of milestones.

The single biggest one is the SUBMISSION (Seeva) of the marketing application to the FDA. It's a pretty sweet hurdle. Submission only. Not triggered by actual approval or anything commercially important like that.

This is Performance Condition 4 of the scheme that was put to shareholders at the 2014 AGM. You can read the exact phrasing in the AGM explanatory notes. The scheme was renewed at a more recent AGM (last year?). Triggering PC4 nets PW 624,975 shares.

Stan will get 25k shares, same for Brenda and Elie would've got 17.5k.

I'm not sure what the specific events are that'll get Wolgen his remaining 299,999. Strange number that.



--------------------
Dr Wolgen is a magician.
His end game for Scenesse will impress, or even amaze.
En route, along with glimmers of truth, there will be distractions, illusions, sleight of hand and misdirection.
Enjoy the ride.

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Johnny H
post Posted: Jun 24 2018, 01:14 PM
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In Reply To: macgyver's post @ Jun 24 2018, 09:44 AM

Clinuvel shifted from a stock option scheme to a performance rights scheme, and they no longer award options.

The average cost for shares awarded under the performance rights scheme is zero. They are granted for nil consideration, so the cost basis of the shares is zero.

When the performance rights are converted into shares, those shares are held in a trust for seven years after they are issued unless the employee leaves the company. They can't be sold without permission.

Short term fluctuations in share price are meaningless under the performance rights scheme.... no cost basis, and can't be sold for 7 years.



--------------------
Clinuvel until my bowels release for the last time.

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ajshare
post Posted: Jun 24 2018, 01:10 PM
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In Reply To: Frogster's post @ Jun 24 2018, 12:33 PM

Correct numbers and performance conditions attached. PW is around 924K
Attached thumbnail(s)
Attached Image

Attached Image


 


 
macgyver
post Posted: Jun 24 2018, 12:55 PM
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In Reply To: Frogster's post @ Jun 24 2018, 12:33 PM

I concur with the number, between 600k and 930k still to be vested. That’s much more palatable.

 


seeva222
post Posted: Jun 24 2018, 12:52 PM
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In Reply To: Frogster's post @ Jun 24 2018, 12:33 PM

Thanks. It's just on submission, not acceptance? That seems like a rather ill thought out incentive.


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Frogster
post Posted: Jun 24 2018, 12:33 PM
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In Reply To: seeva222's post @ Jun 24 2018, 12:00 PM

He wont be getting 5m shares. It's something like 624k shares from memory on submission of the NDA.
3 of the other directors will get a much lower number of shares on submission.
Some of the management will get shares on approval of the application, but the quatum hasn't been published.
There's a huge difference between a trading halt around a capital raising, and the issuance if shares to action an approved reward scheme. I'd be surprised if you ever get a halt for the latter.

If share issuance is involved in this event, it's a secondary item to the regulatory submission.



--------------------
Dr Wolgen is a magician.
His end game for Scenesse will impress, or even amaze.
En route, along with glimmers of truth, there will be distractions, illusions, sleight of hand and misdirection.
Enjoy the ride.

Said 'Thanks' for this post: ignoramus  seeva222  macgyver  Verharven  ajshare  
 
seeva222
post Posted: Jun 24 2018, 12:00 PM
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In Reply To: Johnny H's post @ Jun 23 2018, 04:53 PM

After some wine and a little distance...

Triggering a 5-million share dilution seems like the most plausible reason for a trading halt. There was a halt around each previous dilution.

My question is: Does the trigger come after submission of the final module or FDA acceptance? The latter usually results in a PDUFA date.


This halt was for a paltry 8 Mill. Wolgren will get 60 or so.
http://www.clinuvel.com/investors/news/ite...1c6502bd0016b40

 
macgyver
post Posted: Jun 24 2018, 09:44 AM
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It all makes sense now. Share price dropped $3 so that when PW's 5 million shares are issued, the average price will be lower that $13.56 so as not to incur the wrath of retail investors who will be none too pleased about the upcoming dilution. Or alternatively, the share price was jacked up to $13 so that PW would have a higher average price when his bonus shares are issued.

This means NDA was submitted two months ago, FDA have accepted and issued priority review/PDUFA, and now the attention becomes acutely focused on vitiligo and complimentary/cosmetic products. $20 a share in 12 months.

It's a script.

 
 


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