Ayala Pharmaceuticals Inc (ADXS)

[gbrown6332]

AT-014 Approval Path...

Just finished a fairly deep dive into USDA animal drug approval references. It's a bit puzzling as the references invariably lead back to FDA offices that appear to be the final word on veterinary drug oversight and approval.

This link provides what I believe is the actual path AT-014 must travel to conditional approval. A 9 page overview that defines the various authorities within the FDA who touch or manage the review and approval of new animal drugs.

Central to the process is the FDA Office of New Animal Drug Evaluation - ONADE. It's clear the drug sponsor, PETX in this case, has a key role in pushing the approval process via essential data the FDA ONADE requires to greenlight a new drug for marketing and use.

https://www.fsis.usda.gov/wps/wcm/connect/3667ee98-1f1b-4f79-8094-8bfbcc6c89fe/FDA_Animal_Drug_Approval.pdf?MOD=AJPERES

I searched in vain on the USDA and FDA animal drug databases to find any mention of pending actions for Aratana, PETX or AT-014. Doesn't mean the information isn't there, just may suggest I'm a lousy researcher. The Greenbook PDF of FDA approved animal drugs contains hundreds of references with a small handful of companies clearly dominating the new drug submission process. Our partner, Aratana, had three drugs listed.

Still hoping PETX surprises and hits their stated end of year approval target.

G.B.