PharmaCyte Biotech Inc (PMCB)

[Peacefulwendy]

"Note that a drug that has received a breakthrough therapy designation or a fast track designation can be eligible for the accelerated approval pathway, if the relevant criteria are met."

Thanks joe_techi. Here are my thoughts on the above statement taken from your post regarding the FDAs breakthrough therapy designation.

IMO, with the announcement on Friday, it sounds to me like Cell-in-a-Box may have received or may have been advised that they could qualify for, a breakthrough therapy or fast track designation. I believe this is why they stated that they could qualify for accelerated approval. With Dr Von Hoff leading us through the approval process, I trust he has experience knowing how this works and would be advising as to the steps to take.

The management team at Nuvilx has been very forthright and in light of the above, it seems reasonable to me that they either have received notification or have been advised that they may very likely qualify for breakthrough therapy or fast track designation. Thus, the announcement we received on Friday advising accelerated approval process could very likely happen, imo.

We are constantly advised by the management team to read through the lines and connect the dots. This is all my opinion and, I grow more confident with each move forward that Nuvilex makes.

NVLX ~ Cell-in-a-Box