Anavex Life Sciences Corp (AVXL)

[nidan7500]

This post by Rubyred shows everything we need to know about where CNS trials are going. All we need to do is read and map the new process guidance to AVXL trials plans. The great opportunity that Dr.M. has today is to show some of the link applications.

http://www.pharmexec.com/fda-moves-overhaul-new-drug-review-process-0

Commissioner Scott Gottlieb similarly highlighted how OND modernization will help FDA adapt to important scientific changes in medicine. The overall aim, he explained in a keynote speech at the FDLI meeting, is to better align new drug development and review with new types of medicines designed to target molecular changes that initiate disease, and “not just the symptoms of illness.” This shift will require new approaches to documenting and evaluating applications, including a team-based review process that brings together staff with expertise in areas such as statistics, modeling, simulation, and advanced manufacturing to assess novel trial designs and drug development approaches.

“We want it to be easier to innovate the way drugs are developed,” Gottlieb commented. Our professional staff members are “thought leaders in their disciplines,” he observed, “and we want to give them more time to collaborate with academic medical scientists and patients, to analyze scientific and commercial developments, and to strategically foster drug development.”

New templates
The process for documenting reviews will be revised to highlight issues and data of greatest importance, while also reducing the sometimes-redundant memos generated by multiple review processes. Woodcock noted that CDER staffers are developing a new template for documenting multiple aspects of a review, including toxicology, clinical pharmacology, and clinical review.
A new Office of Policy in OND will play a key role in developing more consistent policies and procedures across disease areas, Woodcock added. This office will facilitate the development of more “bullet guidances” that provide short, timely advice on specific topics involved in developing certain therapies. Such guidances are faster to draft and to finalize, and CDER hopes to issue 30-40 such advisories a year.
Gottlieb further described the OND changes at the annual meeting of the Reagan-Udall Foundation the next day, noting that he expects CDER to begin unveiling these initiatives by the end of this summer. The OND reorganization will establish more focused therapeutic divisions, he explained, such as separating the current Division of Gastroenterology and Inborn Errors Products into divisions for gastroenterology and for liver disease. He also anticipated that a common review template would reduce the multiple memos developed by each review discipline.

IMO, if there are links to new processes at work then Dr.M. has been given the license here by Dr.G. to expand on them as context presents an opportunity. I would like to think that these guys are really that good. We'll see, if the links are there they should jump off the page at us. They could not really come out and say that just about everything the FDA did in the CNS disease space for the past 2+ decades was very sloppy and produced almost nothing considering the massive investments made. But, we all understand that in the not too distant future it all will become painfully obvious. In the meantime all the attack dogs criticizing lack of progress to a set of rules (which they do not recognize have already been shatcanned) will need to develop a new line of metrics on why things are screwed up. Good luck w/that. My suggestion is to mark this down as a learning opportunity and move on.