Wolf, I think that question is company specific. The two "fast track" approvals from last year was a "first in class" drug from Cognition therapies that is in very early trials, its based on bio markers and actually showed no cognitive improvement in their trial, so apparently being "first in class" improves your chance to get the designation while maybe not making it more likely that the FDA believes in your chances of approval.
Alzheon however has a drug that could potentially slow progression/treat symptoms like current SOC. They had some success in P2 but realized by the time they were into P3 that many of the patients actually did not have ALZ, perhaps as much as 30% of those patients (mild to moderate) so they stopped the trial and decided to go with APOE4 carriers because that population apparently only has a 5% "false positive rate". Probably should be a lesson to other companies going after early alzheimer's. I think the FDA thought fast tracking them would save a significant amount of time keeping them from having to start from scratch. Even still probably doesn't make it any more likely the FDA thinks they will be successful even though they got the designation.
Now what would/could be interesting with us is that if we get the fast track status and the FDA works with us to get a certain amount of patients in our confirmatory trial and signs off on all parameters we choose to use, then if we get that confirmation for a severe population with no effective SOC, would the FDA allow for use on a compassionate basis as we run an additional P3? It's not impossible IMO. That's how fast tracking could potentially be blockbuster for us possibly.
News 
Market Data 
Discover 
