Replies to post #261427 on Avid Bioservices Inc (CDMO)

[nh]

CP, good post. I agree with your statements, they seem logical to me and I believe either of these events could still occur. We have some clues to support your statements below. I almost support scenario 2 because I do not think the current process of ignoring historical precedents should be a continued process for the approval of drugs going into the future.

The surprises may come out of what is done with the SUNRISE data. Either sufficiently strong to combine with salvaged PII data that is now available (and is MORE valuable then the PII data PPHM took to the EOPII meeting with the FDA and which the FDA apparently found already sufficient good to allow a PIII) to file a BLA based on 154 patients and the pre-define contingency measures PPHM has build into the SUNRISE protocol (approved by the FDA) to deal with involvement of drugs like Opdivo as 3rd ln treatments affecting SUNRISE

...or...

maybe they file for a BLA chemo+bavi for which the control arm data can be IGNORED (proper to data used in BLA filing is that it may be pre-clinical, PI, PII, PIII as long as there is no PIII clinical trial enrolling - study must be open - and that BTD data does NOT require any comparative arm but must show promise compared to the current treatment).
With SUNRISE stopped this is a possibility.

[vinmantoo]

maybe they file for a BLA chemo+bavi for which the control arm data can be IGNORED (proper to data used in BLA filing is that it may be pre-clinical, PI, PII, PIII as long as there is no PIII clinical trial enrolling - study must be open - and that BTD data does NOT require any comparative arm but must show promise compared to the current treatment).
With SUNRISE stopped this is a possibility.

The scenario clearly cannot happen. The FDA will NEVER throw out or ignore the control arm so that Bavi or any other drug will get approved. You can restart a new trial with a new control alarm and enroll even more patients so that potential chances for a control arm anomaly are reduced.

The FDA will NEVER allow a company to together data from uncontrolled phase I, phase II and phase III (assuming you threw out the Sunrise control arm) as the basis for approval. Just why in the world are proposing to include pre-clinical data. Is it the mouse data or the cell line data that you think is so important? Those two bits of data allow you to get into phase I trials. They do NOT help you get FDA approval.