Thought I might comment in this thread because after reading the...

Thought I might comment in this thread because after reading the other thread it almost seems as if completing recruitment of a blockbuster phase 3 is a bad thing. I don't know of any other Biotechs where good news has to be so relentlessly attacked, geez grizzly reckons this somehow means the company is going to collapse now, but he also thinks Clinuvel having $200 Million in cash might be a myth because some other random company did some fraud once. I still don't know of any other Biotech worth about $300 Million (removing cash) that keeps growing profits and EPS to the point they may well pump out $40 Million NPAT this year even while running a Phase 3 and while not having to profit share with any Big Pharma.

What we know from the company is 200 subjects recruited, 20 weeks treatment and then 6 month follow up for completion around June next year then results 2nd half 26. Yesterdays release said that all case study patients are satisfied with the treatment and it was well tolerated. Furthermore there is an excellent safety track record and years of data on the Clinuvel drug which already has all important FDA, EMA, TGA approval etc. Clinuvel has shown adaptability in altering the trial protocol to make recruitment easier and they have also decided the control subjects will get the treatment after the study so this effectively doubles the amount of hard treatment data they will obtain. There seems to be some real desire to be in the active group and receive the drug as the current standard of care alone is not that effective. Dr Rodenburger looks to be an incredible asset here, she has already proven ability in helping to obtain an approval from the FDA and global Vitiligo expert Dr Pearl Grimes on the board is another asset. The Clinuvel drug is unique here as it is non immunosuppressing. Now for the unknown information outside of Clinuvel, will they need to do CUV107 before submitting the sNDA to the FDA? I guess the study results will determine this and if we get early readouts this year or next then we may find out their plans along with those results. Early indications/photos are very exciting. There were hints from PW at the AGM that we might be in for a positive surprise, but there were also recent strong words about carrying out a share buyback which cast some doubt over this in light of not actually doing what they said with the buyback.

So overall a well done to Clinuvel, timing of FDA submission is the next question. If Disc reckon they will submit for EPP with no phase 3 and a failed time in sunlight endpoint in their phase 2 then the case for Clinuvel submitting based on a solid phase 3 with an already approved drug would appear to be strong. CUV107 should flow quicker now I guess due to study protocol improvements. Also as Epichemist pointed out it does line up nicely with the unique, viral potential, tanning product they touted via Bulletin 2 for next year. Vitiligo should be a transformational event for CUV if approved, Clinuvel forecasts USD $490 - $570Million (from half yearly) for Vitiligo in years 1 - 2 of treatment which is amazing when they only have 50 Million shares on issue, and no one to share profits with, and their own existing, profitable distribution network of centres. Nice cash flow already and an excellent half yearly just reported with strong growth, phase 3 moving along, some very exciting potential, massive cash reserves... it really is the time to carry out the share buyback in full as stated. The daily ASIC data on the shorting manipulation is clear for all to see, failure to implement the buyback is the main detractor on sentiment in my opinion and you would think with their poor history on remuneration votes that they would want to turn sentiment around at some point?

All IMO DYOR