To: Kushi Kullar who wrote (5550 ) 9/1/1998 12:32:00 PM From: Rocketman Read Replies (1) | Respond to
Hard to judge in some ways. One of the classic dilemmas, especially for biotechs (as opposed to Pharmas), of scaling up is that you need to make material for your Phase 3 clinicals years in advance of when you will get approval. This is typically done in a pilot level process and quite often on by contract manufacturers. Then, many years later when you have the confidence that you will get approval and you can raise the cash to do it, you build up to a commercial production capability. Well, the FDA Catch 22 is that your clinical trials have been conducted on stuff that was produced in the pilot level facility, not in the final full production facility, and there are always "changes" to the process. So in the case of an Aviron, they can be hit with another round of clinicals late in the game to prove that what they make now is just as good as what they made before. The reality of this, is that in the vast majority of cases it is anal BS footdragging by the FDA pencil pushers who have no concern for medical advances, but who love to jerk around companies and create work for FDA pencil pushers like themselves - got to have those i's dotted and t's crossed. Now, this is not usually as much of an issue for a major Pharma as they have the money AND the production facilities that they can use to create the clinical batches in and once the approval is made can produce the production stuff identically.
