Avid Bioservices Inc (CDMO)

[Protector]

coporal, about your question:

I didn't read the part about the bla being filed. Another pr tomorrow? CP?

You did initially ALSO NOT read that Sunrise would have a statistical significant overall survival group in Sunrise, yet I did.

Just as you didn't read that biomarkers were on a LARGE group and PRE-DEFINED in the protocol of Sunrise, but I did.

Just as everybody tough Sunrise was death and would yield NOTHING of use for a BLA, yet I kept saying it did.

It is AGAIN NOT explicitly in THIS PPHM PR, but as in the past with hindsight, we know that MOST things I posted were NOT and then suddenly came to live. It will not be different this time. It is THE ONLY topic that remains open for Sunrise BLA or NOT because we KNOW NOW FOR SURE they have the goods and the data.

Now put yourself in the FDA position: A Sponsor that conducted a PIII by the rules, enrolled the minimum require FDA patients, and stops the trial early because of futility of enrolling more, come to them with data acquired in the BLINDED part of the trial showing that:

THEY CAN 100% SURE FILTER OUT 30% of the targeted NSCLC population and can IMPROVE OVERALL SURVIVAL of these patients in a safe way without any side effects of there own, by 74%.

But everybody says: Let's not do it because on the PPHM board they think that if the trial is stopped early the data it yields is invalid EVEN if statistical significant and acquired by FDA rules.

You see why that BLA will come whether it was mentioned in the PR or not.