Replies to post #249457 on Avid Bioservices Inc (CDMO)

[CuresForHumanity]

Bio, I believe someone on this board, 4-5 months ago, stated that the BLA has been in progress for about a year already. So, if this is true and the BLA has now been in progress for almost a year and a half, how long will it actually take to submit the BLA, if there is a trial halt by summer?

[exwannabe]

I would be VERY disappointed IF it takes PPHM 6-months, or longer, to submit a BLA IF there is a trial halt this summer. JMO.

4-6 months (which was what I was thinking, my language was ambiguous) after results for submission of a BLA is reasonable.

The Aviston submission took 4 months (Jun 1'13 data announced, Sep '29 submission complete). And that is with BP resources. I have seen some take over 6.

To be honest, it kind of depresses me also waiting this out. Seams kind of wrong.

But look at reality. The final clinical data set is huge. And it must be current as of the data cut, so can not be gathered early.

And a rolling review does allow them to get the non-clinical sections out of the way, but it will not change the time to submit the clinical section.