|Lots of anxiety here lately. Complaints about taking so long for re-submission and whether Behzad has the skills to run the organization.|
First, if I were CEO of a biotech and received a CRL letter, I'd be damn sure to correct everything beyond mere acceptability and strive for better than expected....to show the regulators that I took the wrist slap as serious.
Second, Pehl came from Celgene, hardly a slouch outfit (though even CELG has had issues with filing for drug approvals) My take on Pehl---he lacked regulatory interaction experience and that was what we needed at the time; consequently, he couldn't appreciate the detail required to go into an FDA submission.
Third: Behzad. He moved swiftly to get rid of Pehl. He did have "experience" in dealing with biotechs through his hedge fund so I believe he figured he could at least set the barrier high enough for re-submission to insure no more screw-ups. AND, he put Charles Baum (CEO of Mirati and another large and successful Behzad holding) on the Board, no doubt to offer assistance in doing a correct re-submission. Losing a year in biotech is very dangerous and, in many cases, it can be fatal. I hope we will still have a competitive edge once the re-submission is done....but the jury is out as to whether "silly" will be a viable word until the evidence is further developed.
Like many here, I regret the past mistakes and I remain of the belief that Behzad has figured things out at long last and we will have a successful re-submission. If he fails gain, the game as we know it will be over and the asset auction can begin.