Replies to post #205619 on Avid Bioservices Inc (CDMO)

[edcpf]

To be fair, it was already known in 2012 that they will not be experimenting with early clnical evidence and such for the Phase III. Thus, survival is the only good solution for this trial.

[geocappy1]

Or that the one early randomized trial that clearly showed the benefit was sabotaged and therefore could not be solely relied on for BT designation.

It doesn't have to be that hard. Bottom line is the sabotage allowed all the other BPs to get ahead and get their I/O drugs out in the limelight before pphm could raise the bar needed in overall survival. Mission accomplished. PPHm delayed 3/4 years but maybe just maybe a little mitigation in the way of not underselling their science to Abbvie because their MOA was less clear.

[Protector]

ITF, this is wrongly analysed IMO.

You left out the word NEVERTHELESS with which your reasoning DOESN'T hold any more.

nevertheless lack the early clinical evidence or magnitude of effect

If you demonstrate "the potential to improve treatment" then "lack of early clinical evidence or magnitude of effect" would be OK, which does not mean it isn't there.

By the way, we do not even need to make that point, the FDA accepted a NEVER SEEN improvement of 60% over SOC in our PII.

Now the below is quite a strange conclusion:

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.

A) Garnick said they DID NOT file for BTD
B) Hence the FDA had to think nothing at all
C) Not applying doesn't make Garnick a fool at all, it is a strategic choice and I'll go for Garnick's choice over your opinion every day.

That is not correct. If they would not get the BDT (say because procedurally they run in an obstacle - possibly due to the dose swicthing -) they the stock would SUFFER.

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.

And apparently this is wrong too because we have a Fast Track and no BTD. So the FDA gave us the resources because by giving us the Fast Track they COMMIT resources to PPHM.

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.