Avid Bioservices Inc (CDMO)

[Protector]

exwannabe, it would be nice if you could, in the same detail as I explained why they could file for a BLA and have some chances, explain to us your statement (red part):

It would clearly be a complete waste of cash and resources on a submission that would be promptly "refused to file" by the FDA.

I posted the link to the FDA showing PPHM can file and I elaborated on what they have and they have everything needed to file PLUS a number of Jokers in the SUNRISE protocol which we have generically heard of but don't know the details.

So what are the reasons the FDA would refuse the filing (the more that parts of the filing have already been done under the Fast Track granted by the FDA.

So you must mean REFUSE FURTHER FILING. But on what grounds? Because your statement above sounds arbitrary to me.