Replies to post #89540 on Avid Bioservices Inc (CDMO)

[biopharm]

Great Post! must see for anyone that doubts AA...and good link that clearly show Accelerated Approval is within Peregrines reach as long as the data continued to trend as positive as they last reported! Sept. 7 will know much more and BP's will be watching closely!

[nuke661]

Purpledawgs,

Very good find. Thanks for finding a document that actually spells out the common sense at lot of us have been discussing lately. Its just too bad that it takes so much effort to convince supposed experts in biotech investment field of what is an obvious common sense approach as to how OS should be assessed relative to other surrogate data. But then again this type of challenge (no matter the underlying motive) makes us all better informed and more confident in our decisions.

[Thurly]

THAT, it a brilliant find.

[Protector]

Nice find and I don't want to spoil the soup but slide 1 says :

Not an official FDA policy

Question is what is it worth if it is not an official policy? Will files be processed by a non-official standard ?

Do we really need to count on all that? Aren't the results going to be sufficient on their own?

[mojojojo]

purpledawgs,

Thanks for posting that. This slide is relevant.



The bavi trial has the RR as the surrogate endpoint and survival as the clinical benefit endpoint. Here's an example.

In oncology, the approval of oxaliplatin as a component of combination second-line therapy for advanced colorectal cancer demonstrated the use of an interim analysis from a randomized trial to support accelerated approval. Accelerated approval was based on objective response rate and time-to-progression evaluated at a prespecified interim analysis, with the proposed demonstration of clinical benefit (survival) at study completion (48).

http://jnci.oxfordjournals.org/content/96/20/1500.full#ref-48