Replies to post #266775 on Avid Bioservices Inc (CDMO)

[exwannabe]

Yup, they can submit a BLA. There is nothing that prevents this.

If PPHM did so, the only question the FDA would have would be if SK was using an FDA approved drug that had delusional/halucenogenic side effects.

[bidrite]

The requirements are simple:

- BLA action letter
- BLA Action Package (with EVERTHING of this STUDY - not just SUNRISE PIII)
- Production Facility data (prior to an approval)

PPHM has EVERY SINGLE PEACE of that.

So since they haven't yet filed a BLA and if they don't do it within a reasonable timeframe, what would you conclude about the data we have available so far? Does stopping ALL chemo trials give any indication as to the probability of us actually having enough credible data as to file a BLA?

Also, are you suggesting we are going to file or only speculating on hypotheticals that are technically possible, although not entirely probable? If that's the case there is no end to the possibilities.

[ku]

CP and Fellow Long Shareholders, based on your common sense post, if the BOD do not file the BLA then they should be FIRED.