re: Ann: Clinuvel - strategic focus of final ... The pieces of the puzzle are starting to come together. This update is excellent news! If the EMEA are suggesting CUV undertake paediatric trials then they must be very confident that the drug is safe and effective.
CUV have ditched SU because they now know EPP is a certainty for approval. They will probably do the same with AK when p2 is complete. PDT was also deferred and it has more potential patients than AK (hence they wont pursue AK to p3.)
In my view (now) SU, PDT and AK were just backups in case EPP didnt come through. Theyll keep PLE because even if results arent spectacular the market is so large that ongoing trials etc will facilitate off label sales for this indication. SU AK & PDT are rare and/or severe enough that off label sales will happen anyway (and will probably start with these patients.)
The key driver of sales will be pricing. They are suggesting higher prices for EPP on approval (assuming its covered by insurance) but it wont take long for the price to reduce enough for off label use. These guys know where the money is, they just need to follow the right step to get approval.
I suggested a while back that wed still see final EPP results by end of March and the MAA would follow shortly after. Todays announcement isnt conclusive one way or the other but Ill stand by my comment for now.
Good luck to all!
re: Ann: Clinuvel - strategic focus of final ... The pieces of...
Add CUV (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$13.87 |
Change
-0.090(0.64%) |
Mkt cap ! $694.3M | |||
| Open | High | Low | Value | Volume |
| $14.00 | $14.07 | $13.84 | $834.5K | 60.01K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 1134 | $13.86 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $13.89 | 127 | 1 |
View Market Depth
| Last trade - 16.10pm 10/10/2024 (20 minute delay) ? |
| CUV (ASX) Chart |