Avid Bioservices Inc (CDMO)

[EYEBUYSTOX]

CSM set us back a year

I would argue it set us back 3-4 years. Ibrutinib received breakthrough designation in January for CLL. They filed an NDA 5 months later. They expect FDA approval later this year. I've looked at the phase 2 data it was given this priority treatment based on. Bavi's 2nd line NSCLC data was more compelling than ibrutinib's before the "incident".

Now, we have no expedited pathway and a 600 patient trial to enroll without a partner as of today. PCYC's market cap increased 1.8 Billion the two days after they filed their NDA. It's scary to think where our PPS would be in a similar situation if the "incident" had not occurred.