This stocks drug does not have a chance in hell of being approved by the FDA. Are you f'ing kidding me? The FDA is going to set a precedent that "Yes we do accept mishandled phase 3 trials" as long as you make up for it with abstracts, proffesional opinions or modified data enumeration? They will be required to redo a portion of their phase 3 when they are issued a CRL by the FDA in October or sooner. Never once has their been a drug with a messed up phase 3 trial that was approved right away on the action date. Never. Go ask CTIC management or DSCO. And those drugs are for unmet needs for chrissakes. Sure we will see a runup to $6 or so over the next few months but Ill see you at $2 shortly thereafter. My advice: use options to your advantage.
"Never once has their been a drug with a messed up phase 3 trial that was approved right away on the action date"
Actually VNDA failed their ph 3 primary endpoint and got approved on PDUFA date last year.
And there is another one that was in almost identical situation as BIOD that got first pass approval and they had to exclude anomalous data. Name escapes me right now, but I'll post it tomorrow when I come up with it. I'm sure there are many more too.
Difference with BIOD here is 1) this is a 505 b(2) and that means a lot lower hurdle and 2) the anomalous data is very explainable 3) plenty of statistical power even when excluding India b/c the drug worked so well at the U.S and Germany sites.
Nevertheless, it is possible we get a CRL in october. I just don't think BIOD will have to do another trial though. Just respond to FDA questions if they get CRL. Slight delay at most.
The magic word 505b2!!!! If biod had any suspicion about the FDA not approving this due to the India issue, they would have not submitted. It would have been to easy to run another study, especially one that has 80 patients. Heck you can run down to the nearest endo doc an grab 80 patients for a study. The bashers here are probably friends of mannkind....IMO. I can't wait to say I told you so!