There have been recent complaints to the FDA about some of the drugs that have been given accelerated approval. Some have shown to be not as effective as first thought, and the associated pharma have kept them for sale, when the FDA has asked they remove them. 2 recent cases like this.
Remembering that fast track approval is only given to a drug addressing an unmet need, the FDA has acknowledged its an important process, that offers the only hope to certain patient cohorts.
So the fast track process is being looked at, with an aim to still have a pathway to deliver effective drugs to those suffering from disease with no effective SOC, while at the same time ensuring robust testing of trial results.
The FDA has acknowledged that the patient cohort concerned have no other choice than a new drug, so are mindful not to place to many road blocks into the fast track process.
PTX did the right thing by disclosing this possible change. But. safety and efficacy of PTX100 so far. would suggest it may not be effected by any change. But noone will know for sure until application is made to the FDA.
Possible fast track (however that looks in the future) and ODD adds value to PTX100's potential. Same for PTX200. And then there is the Cell tech and Omni Car.
Another ozzie biotech talks about multiple kicks at goal. Keeping with SYCs military description of OmniCar, PTX has multiple kicks at goal, but seem to be using a CIWS to fire the shots.
PTX Price at posting:
14.5¢ Sentiment: Buy Disclosure: Held
