Replies to post #107575 on Avid Bioservices Inc (CDMO)

[RRdog]

Thank you Bungler for that excellent answer to CP's question. It was terse and to the point in your usual style.

SK has long stressed the importance of safety data. My understanding of the 2nd line NSCLC test is that whatever coding corrections are used the safety data was abundant.

Of course the other audience that PPHM is talking to is BP. BP's have a whole different set of criteria for "milestone partnering" drugs (or drug platforms) they think might be "efficable" than the FDA has for acceptance. Usually, BP raises the stakes as each milestone is passed.



Best Regards,
RRdog

[Protector]

Bungler, thanks for this clarification. Actually that statsig thing was the only thing in the complete results announcement (and comments afterwards on this board) that troubled/worried me.

If 3mg arm is unaffected, our safety profile, MOS and survival are good (say at least as good as they were on Sept 7th) and if statsig can't spoil it, then I really don't see any obstacles to move into PIII.

My problem was to be able to "assess" the importance of statsig in this stage PII and with what you posted now that worry is gone. Thanks.

[DrRocker]

Bungler and group,
I agree that the stat sig and P value is not an issue in getting the FDA to approve Bavi for a phase 3 trial for 2nd line NSCLC but it could have been a factor in a possible accelerated approval or outright approval contigent on a phase 3 follow up. IMO this outcome, though with the slight chance it might have had, was the biggest short term casualty of the coding errors.
Rocker