Shorts are trapped, page-11

Anyone care to give estimates of what chance they think Vitiligo will get FDA approval, given the drug Scenesse is already FDA approved? A lot of other stocks are hyped and given much higher valuations on lesser pipelines which are only phase 2, not that much discussion here considering it is a potential blockbuster and only about two years away.

* Previous Phase 2 results were very strong.
* Current Phase 3 targeting darker skin types should prove even more effective.
* Excellent evidence of results presented at AAD this year - everyone should have seen the photos by now.
* Expert panel of Vitiligo members assembled by Clinuvel.
* Probably biggest point is the drug is already FDA, EMA, TGA approved and proven SAFE with many years of success.
* Statements like this from the recent Sydney presentation quoting a Vitiligo expert panel member "Once on the market, SCENESSE® will clinically become the pigment booster for every dermatologist in North America"
* Psychological factors of people with Vitiligo on large parts of their body being recognised.
* Drug is also not immune suppressing with the associated side effects, ie superior to existing treatments.
* Clinuvel with recent track record of gaining an FDA approval in 2019

Given all that and remembering the drug is a tanning/repigmentation drug which is beneficial to the Vitiligo disease, plus throw in some gut feeling, and IMO it must be somewhere around a 90% chance of approval? There is still plenty of work to do and maybe the main factor of risk is if Clinuvel stuff something up with the paperwork etc IMO but they have had a lot of FDA interactions over recent years so that is also a positive.

If approved then CUV should have their 120+ US centres ready to go so uptake can be rapid given they have an existing supply chain for EPP and insurers are familiar with it now. The current Vitiligo Phase 3 was mentioned in the Sydney presentation as "12-month recruitment (to October 2024)" so that is seemingly on track and years 1 & 2 sales are forecast as many multiples higher than where things are now on the small EPP indication - and much higher than PME pumped out with the below figures from the last financial year or even what they will pump out this year.

Pro Medicus FY2023 Revenue $125 Million, Profit after tax $60.6Million. Current Market cap $11.8 Billion. P/E 194
Clinuvel, FY2023 Revenue $78 Million, Profit after tax $30.6Million . Current Market cap $0.78 Billion. P/E 25

I still like the CUV risk/reward set up, interested what others are thinking with Vitiligo.

All IMO DYOR