Replies to post #14031 on Ayala Pharmaceuticals Inc (ADXS)

[Julius_Kelp]

Quite possible, FBG. PETX did file with the USDA around July 2014, so where's the holdup?

http://ir.advaxis.com/press-releases/detail/694/advaxis-announces-filing-for-usda-product-license

[glbeaty]

PETX never mentioned 2015 in any source I can find. Unless you have a source, please stop misrepresenting their statements.

This is the first mention of an AT-014 timeline I can find from PETX: http://seekingalpha.com/article/2415395-aratana-therapeutics-petx-ceo-steven-st-peter-on-q2-2014-results-earnings-call-transcript?part=single

AT-014 will receive a conditional license by 2016.

http://seekingalpha.com/article/2670785-aratana-therapeutics-petx-ceo-steven-st-peter-on-q3-2014-results-earnings-call-transcript?part=single

Yes. So AT-014 program is a cancer vaccine for osteosarcoma and we have submitted some data to the U.S Department of Agriculture related to getting a license that we actually haven’t communicated, John. We’ve said that’s sort of -- best case would be 2016. So that’s kind of where we’re on that. And until we have the full interaction with USDA, we won’t actually know where we’re in that, but we’ll communicate as we have interactions with what we think the timeline there will be. One of the interesting things about the USDA is, they don’t really have the formal guidelines and timelines that the FDA Center for Veterinary Medicine does. So it’s nice, because you talk with them, you work with it, but it makes a little confusing, because it’s hard to talk about timelines in the way that we talk about them with a lot more certainty related to FDA programs.

ADXS did anticipate a response from the USDA in 2015, which I believe was something to the effect of "do another study".

[ignatiusrielly35]

Yes, FBG, that is the claim against Aratana. However, there is a big difference between missing on a clinical timeline (in biotech it is almost a given) and intentionally misrepresenting a timeline. I'm sure therein lies the rub here.