My opinion on the scenario IF the FDA sends back the IND for more information/testing/data is one of dire straits, at least for a while.
This company has its negative history with the FDA, and though I do not think this will weigh against them (at least it ought NOT to), I can see where the FDA would probably scrutinize THIS application with a super fine tooth comb. If it gets sent back, will we be told WHY it has to be redone, WHAT is wrong (unacceptable), or HOW LONG it will be for the next submission? Maybe there's a protocol for this in the IND rules, I don't know.
But for an investor base whose every thought for the last 4 years has been focused toward an ACCEPTANCE of just a single IND to be disappointed at the last minute - once again - would spell bad news for any price hike that had happened up to that point in time. Not that it can't get past a deferral by the FDA of the IND submission, but rather to have semi-failure at the height of anticipation might cause many to lose faith. In my mind's eye, that would a large stumble.
I think that every IND's owner would want approval first time around, but ESPECIALLY for this company - it is a must do scenario at the first crack. None of us know what the future holds, and I am sure Globomax and ADVR are doing _ALL_ they can to insure a first submission approval. But the leverage changes once the IND is submitted, out of the company's hands into the grasp of an entity over whose deliberation they have no control.
Scary. It WILL be a most exciting and perilous journey and ride...and I'm up for it! |
