According to that pdf from July 12th 2024, Clinuvel once again...

According to that pdf from July 12th 2024, Clinuvel once again reaffirm the blockbuster Phase 3 into Vitiligo seems to be tracking well. FDA submission in just 2 years 2026 stated. Vitiligo TAM mentioned $4.5 BILLION USD and likely 9% penetration years 1-2 giving $490 - $570 Million USD. Lots of centres already set up to administer and more to come - targeting 120 with each one handling about 50 new patients per year (ie ~6000). We have seen the compelling evidence of the effectiveness of Clinuvel treatment of Vitiligo and the very supportive statements from the expert panel Clinuvel wisely assembled. I think standard of care very likely and the beautiful thing is the drug is already FDA approved so safety very well established and the path to approval much easier. Just looking at those numbers it can be seen how transformative Vitiligo will be for the company, and it is close. Short sellers seem to be betting it won't be approved along with everything else in the pipeline (but the shorters were wrong about FDA approval already), not to mention the absolute CUV monopoly position and cash printing current profits with no competitors even close to entering the EPP market.

We need to start talking about Vitiligo and how transformative that will be for Clinuvel if approved. Also how likely does everyone think approval is considering the drug is already FDA approved, very safe and very good at doing repigmentation? What will the CUV share price be in a few years with $500 Million USD new revenue dropping in considering their very low distribution costs and no big pharma to share profits with? Only 50 Million shares on issue now and 48.5 Million shares after the buyback. So Vitiligo + EPP revenues in 2 full years after approval would be around $900 Million to $1 Billion AUD. And you can get a shot at Vitiligo and the rest of the pipeline including Stroke, Tanning, VP, XP, Neuracthel and Parkinson's disease for free right now with the share price at 5 year lows. I am guessing the share price will only be much higher than it is now if any single one thing comes to market, while the current pricing which shorters have spent a lot of effort manipulating and maintaining suggests nothing is going to happen when Clinuvel have already shown ability to gain an FDA approval and generate profits unlike pretty much 99% of all small biotechs. I suppose another question is why are Clinuvel so poor at generating investor interest (we can compare here to cash burning potential competitor Disc) despite having three investor relations experts on three continents? Daily volumes in Australia are nearly always very low and mostly manipulating/churning while volumes in Europe and the US are almost non-existent.

Many or most small loss making biotechs and mining companies and tech companies are hyped and valued on the possibility of being able to make some money in the very distant future - or certainly further off in the future than Vitiligo is with Clinuvel - yet they have a steady stream of interest and hype. I think at cashed up and very profitable CUV it's more realistic and possible to talk about such a transformative event because it's not that far off.

All IMO DYOR