Anavex Life Sciences Corp (AVXL)

[Rubyred77]

Tweets from Gottlieb yesterday:

Seamless trials, used in oncology for drugs that might qualify for breakthrough therapy designation, are another novel approach https://bit.ly/2NQy52K . They compress the traditional 3 trial phases into one large, continuous trial that may be able to speed access for patients.

A lot of time and cost is spent between the starting and stopping of the traditional 3 phases. Continuous trials can save time, lower costs and reduce the number of patients. Look for new guidance soon from #FDA on how developers can conduct these “expansion” trials

#FDA is working across our medical product centers to facilitate innovative trial designs and patient-centered endpoints that can make clinical trials more rigorous and efficient.

And FDA has encouraged several pioneering advances in clinical trial design, including Master Clinical Trial Protocols (MAPs), first used in cancer and now used more widely across FDA, in other therapeutic areas

https://endpts.com/weve-scheduled-your-type-t-meeting-with-fda-commish-scott-gottlieb-where-you-can-learn-the-art-of-rapid-fire-rd/