Replies to post #150455 on Avid Bioservices Inc (CDMO)

[dia76ca]

Bio.... I will just trust what Dr. Garnick said about the FDA approval of the NSCLC Phase III trial.

Robert Garnick: ".... They liked the plan we proposed. They thought it was well thought through, and there were absolutely no sticky issues whatsoever."

[exwannabe]

jq1234, here is some more info that may change your mind regarding the use of blood samples which will be allowing the FDA to make approvals and Roche just had a drug approved based on this very method - of blood samples.

I would not think a pCR in any way equates to using some sort of immune assay as a suragate endpoint.

I would have no issue if people here were suggesting some sort of PR/CR endpoint for approval. That shows that the cancer is being killed. Kind of reasonable to assume that this will be a clinical benefit..

But an immune response (as of now) does not do such. All this shows is that the immune system is reacting to the drug.

[eb0783]

I know you are trying biopharm but: These guys may be ones who are still making the best buggy whips in the world (those of you who may have had Quality training years ago will understand this.) OR they may be in the group that I mentioned back on my post on 10/22: “all in my opinion: some of US believe in the traditional American way of building things and of producing things and gain/profit by building value. That production and value building generally improves the economy and people benefit from the products or services. Then there are those who believe that making a profit whether by building OR destroying is what they should be doing. So they are just as happy to destroy a company, a company that may be creating the next best thing for humanity, as long as they can profit from it. They find that these smaller companies without products are easy pickings, but how many lives have they taken (Fargo like and otherwise) in the process.”

[jq1234]

pCR: That's in neoadjuvant setting, doesn't apply to 2nd line setting at all! Your ph2 trial didn't have any CR, how could it have pCR?

[biopharm]

"approval was based on data from the HannaH study which showed that the subcutaneous formulation of Herceptin was associated with comparable efficacy (pathological complete response, pCR) "

Interesting times....as we are clearly moving into blood tests...or liquid biopsy and yes, this will end up leading to pCR Pathoogical Complete Responses....likely from those in Sunrise that we were told by Peregrine to be still on Bavituximab treatment

pCR .... and ORR ... both helping and leading to primary endpoints in future trials