Yes, the intention will be for a registrational trial.
Steven has obviously decided not to go headlining this in an official ASX release, erring on the side of reserved expectations .
It's not Professor Miles Princes role either to go flagging any possibilities of a registrational trial.
However Steven has mentioned multiple times that it is his objective to push the FDA for a registrational trial for PTX-100.
I think Steven will be having very serious conversation right now with the FDA for designing the next phases framework around a registrational trial. With orphan drug status already granted by the FDA, excellent safety profile, fantastic responses beyond SOC currently available...Why should we not be optimistic for the FDA to grant a registrational trial?
Given the unmet need and proven safety profile of PTX-100, it appears to me the risk for the FDA is not approving the registrational trial.
We wait and watch for the FDA decision in the new year.
Excellent work team PTX.
- Forums
- ASX - By Stock
- Ann: PTX-100 Ph1b results show excellent safety & efficacy in TCL
Yes, the intention will be for a registrational trial. Steven...
-
- There are more pages in this discussion • 31 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add PTX (ASX) to my watchlist
|
|||||
Last
3.9¢ |
Change
-0.002(3.70%) |
Mkt cap ! $31.40M |
Open | High | Low | Value | Volume |
4.0¢ | 4.0¢ | 3.9¢ | $31.53K | 794.9K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
8 | 456872 | 3.9¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
4.1¢ | 66952 | 1 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
8 | 456872 | 0.039 |
12 | 1469182 | 0.038 |
2 | 103515 | 0.037 |
5 | 429500 | 0.036 |
5 | 313576 | 0.035 |
Price($) | Vol. | No. |
---|---|---|
0.041 | 66952 | 1 |
0.042 | 380000 | 3 |
0.043 | 300000 | 2 |
0.044 | 210000 | 2 |
0.045 | 407000 | 3 |
Last trade - 15.43pm 24/06/2024 (20 minute delay) ? |
Featured News
PTX (ASX) Chart |