Replies to post #111618 on Anavex Life Sciences Corp (AVXL)

[Gator328]

Talon, I agree in theory...

I just think that the FDA would be more likely to give the RMAT designation to drugs that are further along in the clinical development than 273 is at the moment.

Is 273 a candidate down the line? I absolutely think so, but for now, we have to temper our expectations with regards to buyout offers, FDA labels, etc because all things considered, 273 is still in its infancy in the drug development timeline.

A proper P3 trial will probably take at least a year, maybe longer. And we still have some time for the extended P2A; I suspect that Anavex isn't going to want to push forward with a new trial until it's extracted as much data as possible from the current one so as to maximize odds of success when the trial is blinded and controlled.

[nidan7500]

Is this an explanation for delays...right in front of us all along???

To continue to advance these opportunities, we’ll be announcing this September a comprehensive framework for the development and proper FDA oversight of regenerative medicine. This new policy effort will comprise a series of new guidance documents covering many aspects of the regulation of regenerative medicine products. It will be announced as part of our Innovation Initiative. It will delineate our policies for appropriate and efficient regulatory oversight of regenerative medicine products, in order to demonstrate their safety and effectiveness. It will also create an accessible framework that will enable providers to more easily collaborate on proving these principles for regenerative products that are advanced within local medical institutions. We want to help facilitate these scientific advances, which hold out tremendous potential for treating and even curing diseases. To achieve these goals, we need to make sure that we have a modern regulatory framework in place that can allow innovators to meet the statutory requirements for demonstrating safety and effectiveness. "


https://blogs.fda.gov/fdavoice/index.php/2017/07/how-fda-plans-to-help-consumers-capitalize-on-advances-in-science/