Replies to post #131067 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

In terms of the disease-specific guidances, was there a reason you picked that route?
Gottlieb: A lot of this comes out of consultations with the centers. So you talk about what their priorities are and then you try to marshal the resources and accelerate what they aim to do. I think that they’re looking at areas where there is no disease guidance and there’s a lot of product development and there’s unanswered questions, and they get a lot of questions. Where is there a significant unmet medical need? So those are the kinds of criteria that they used in adjudicating that. I didn’t pick the 10 areas, the expert groups picked them.

[/u

[tredenwater2]

Thank you TTT for the post. The second to the last paragraph stood out to me as a possible reason (aise from the mountain of paperwork Fadiran is submitting) for the thoroughness of the FDA and Anavex.

"We weren’t working in a 24/7 news cycle. That’s very challenging for a regulatory agency, especially when you want to be responsive and you want to make sure you’re putting out information and you’re responding to things that are being talked about or things that might be in the press. Because as a regulatory agency, we have to clear everything through five chains of review and make sure the lawyers saw it. And we’re looking at Twitter and things are being put out that might misinterpret things that are important to us from health standpoints. That’s a big challenge, too, operating in that kind of news cycle."

Excellent! I believe Dr. Missling and Dr. Gottlieb truly understand the gravity of what they are about to announce. "Are you ready?,...." " Yup Im ready, lets go!"

I love reading or hearing Gottlieb speak! He sounds and acts very qualified for his position to bring forward the 21 Century Cures Act. Thanks again TTT.

Tred