If the Phase 3 trials prove successful will the FDA approval be a slam dunk, 50/50 shot, better or worse? Anyone can answer. I'm just curious, I know there will be alot of ridiculous statements, just looking to hear thoughts.
Here are some concrete numbers for you to work with... 90% of all NDAs are ultimately approved, some after a CRL (complete response letter) or two. So, assuming the phase 3 results are good and MNKD submits an update to its NDA, the odds are at least 90% for approval. Throw in the fact that the company and the FDA worked so closely together on the last two trials, the probability goes even higher.
from my understanding Mr. Mann/MNKD worked very closely with the FDA in designing the Affinity 1 and 2 trials-if all the objectives set out by the FDA are met/exceeded I can't see how they can not approve Afrezza or send another CRL letter
I think voicy and Clevans sum it up perfectly. Could list a bunch of reasons, but they have all been discussed to death during this waiting on results! Phase 3 results are successful, I have to say 99 to1 for approval, also! and I am leaving the 1% for the fact that we are dealing with the government.
Phase 3 is good to great, this is the closest thing to a slam dunk that I have ever seen, and I'm in my late 50's GLTA longs!!!