Avid Bioservices Inc (CDMO)

[JJ1223]

Quote
"Without a partner you have a very strong chance of not getting FDA approval"

Peregrine and the FDA have agreed to the structure and required milestones for the Sunrise Trial. It is being monitored by an outside firm. If the milestones and endpoints are met, Bavi will be approved with or without a partner. I would agree with you in only one aspect. If a company did not have the proven capability of producing the required product, without a manufacturing partner, approval would be withheld. This is certainly not the case with Peregrine/Avid. The sales/distribution side is a different animal, and a company does not get this far without much thought on the topic.

I do not believe however, that PPHM will go to market without a suitable partner