There was a time I'd have said you were right, but that was long ago. I've seen how low IMGN got only to come back, but the best example I can think of is CVM, I really can't say how many times their one drug has failed, without improvements in that sole product they keep finding new targets, and find new investors to support their trials. Who knows, this time they may have actually found a disease that works with their drug.
I don't believe it will be necessary, but in the past I've seen such bizarre action from the FDA that nothing is impossible. I think we'll get UK approval, and that alone could support additional requirements the FDA or others might impose. It's sad, but the regulators all too often don't think of the sick people who lose access to promising products when they insist on added trials, but that's clearly the case.
I've probably anticipated approval of a dozen or more drugs that I had no doubt of approval. I would guess that at least a third of them had delays, some over three years, but all were eventually approved by the FDA. Confirming trials could have been done post approval, and perhaps the FDA is doing that more frequently now, but years of delays, and hundreds of millions in additional developmental costs doesn't seem to bother the FDA at all. Meanwhile, certain products which their advisory committees advise them against approval get approved. Go figure.
I frankly believe that all trials should be shorter, but all approved products should be tracked in Phase 4 cataloguing of all uses which are reviewed to determine whether any additional cautions or labeling changes should be required, or worst case if they should be taken off the market.
Gary
Bullish
