Replies to post #169047 on Anavex Life Sciences Corp (AVXL)

[Amatuer17]

Well - you did more precise timeline and I tend to agree.
Be ready to get a backlash for pushing trial end to 2020-2021 and how you are impacting the suffering girls.

[Talon38]

Doc.....you have been intimately involved with previous trials so I trust your analysis of the timeline of the RS trial. However, as we discussed sometime back, I think your timeline is somewhat conservative. Given the close relationship of the patients' families with the RS Foundation, the data from the Natural History Study, the dedicated Rett Syndrome Centers of Excellence and their experienced staffs, the administrative aspects of the trial should move expeditiously. On the regulative side, if the FDA uses the modern precision medicine model of seamless and adaptive trials, imho your more conservative timeline could be considerably accelerated. With notable improvement in the quality of life of the RS girls along with a good safety record, there will be powerful advocacy from parents and worldwide RS organizations to get 2-73 to market. We must remember this a very debilitating disease which affects these girls and their families from birth to death which can be over four decades......much longer than the average Alzheimer's patient.

[avxl_going_long]

Doc328, the PR says FDA approved Phase 2...why are you and others here saying this is a Phase 1 trial?

[nidan7500]

Doc328...question.
First, thanks for your contributions here over time.
What impact do you think any positive results from initial testing/screening will have on timing?
Is the system capable of adapting to positive (read effective) responses from first testing? At present these kids do not have a chance. Do we expect everyone to calming standby if first kids start to recover some key function?

I sure don't.