Avid Bioservices Inc (CDMO)

[Protector]

exwannabe, I think that at that time the BLA might not have been submitted, even partially. The reason I think that is that Dr. Darnick spoke about those 500K pages and explicitly added they had them 'electronically'. I checked the slides and slide 34 says exactly that.

...The CTD IS CURRENTLY an electronic document...

So I am 100% SURE that he was talking about the CTD/BLA of the 2nd ln NSCLC Study and that they HAD that information already BUT there is (or was on the annual of 2014) no single indication or sentence that made me believe it was filed BUT Garnick does at that time emphasise the facilitations of serial submission (what we have called partial filing) as a result of getting the Fast Track from the FDA.

Then again I might have missed it. Dr. Garnick's presentation was quite long and you could feel the attendants getting LITERALLY pain in their a..sses from sitting there. I will have to admit that it was not very easy to stay focused all the time.

So since North gives reliable information I will will say it might have already been filed partially with the FDA at the time, I just must have missed Dr. Garnick saying it.

More interesting is that Garnick estimates the TOTAL TIME needed to make all the documents to 6 MONTHS. 18 Months past since that presentation and those 6 months would include data that PPHM didn't have yet, namely the SUNRISE results. So it is very reasonable to assume that they had ALL the time to deal with the 500K pages and started filing thinking they only needed to add the SUNRISE results when available, which would then take much less then 6 MONTHS. That is all the benefit from getting a Fast Track otherwise what use to get it and not use its main advantage.