I cant tell you how many times I have seen such panel thumbs ups and recommendations and green lights only to be shot down by the regulatory agency like FDA. Remember CHTP?? EYCT??? DSCO????
so many others in that club. Panel always recommends, stock pops up huge, then the stock deflates slowly and steadily like an ever so slow leaky balloon for months until one day FDA, etc...reject it and say go back to square 1.
have you not seen that trend before????? i thought its standard practice in bio company universe
Orphan drugs have a much higher chance for approval. This drug is quite revolutionary and efficacious for patients not on antibiotics. Phase 3 is in the bag since the right patients are being enrolled.