Replies to post #205618 on Avid Bioservices Inc (CDMO)

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This statement about Fast Track should have also been highlighted:

The Perfect Candidate: Fast Track designation is best suited for promising drugs with the demonstrated potential to improve treatment of serious conditions that nevertheless lack the early clinical evidence or magnitude of effect required for Breakthrough Therapy designation.

There were many discussions during the past two years in regards to Breakthrough Status but it is kind of interesting that it seems like the FDA must have felt there was a "lack of early clinical evidence or magnitude of effect" with Bavituximab in early clinical trials.

One has to wonder if Peregrine Applied for BT and was denied due to their requirements and that was the reason Garnick was bad mouthing BT Status.

Or did Peregrine not apply at all for BT which would seem like Garnick was a fool in not at least attempting to file for BT status because either way, nothing would have been lost but a lot could have been gained. This is especially, important in that the FDA puts the "Fast Track" status at a lower priority than Breakthrough status ; therefore, the FDA assigns more resources for the latter.