Anavex Life Sciences Corp (AVXL)

[nidan7500]

The reported conversation with IR on IND status is very encouraging news. Some of us have suggested a scenario similar to the one described by IR. A study of what has been published by the FDA on new IND-Precision Medicine protocols also indicates we are doing what was expected working with the FDA. We could not predict how much time would be required to do the back-forth planning/critique but months(not weeks) are to be expected. Anyone with any FDA interface experience can see what is being done. Extreme caution must be exercised at the trials expectation/RWE/PR-news interface. The work must be done well and it must be reproducible. Expense and time must be forecasted while day to day conflicts are resolved. Conflicts galore.

Go look at what the FDA has already released on the topic (we have posted the links here a while back with discussion). The FDA has established a structure/framework of the trial design with required checkpoint with emphasis on what not how and RWE-patient interface-takeaways. It all reads to me like they expect tp rely heavily on pts/RWE and being as flexible as possible in interpretation. Nothing at all like conventional FDA trials. What would be unknown at this point is what clinical/pts evaluations must be done, at what point in the protocol, what will/must be measured and when, what pass/fail acceptance criteria (if any) will be used and when applied.

We must keep in mind that these CNS diseases have NEVER been effectively treated. Even though pre trial information establishes basic expectations no one has ever been here before. Not only do we need results to be precise and meaningful but we better not make an error b/c the entire pharma world has just had it's collective ass handed to it. We can intuit that something very important will eventually come from this molecules testing. Let's hope it is soon but sadly we have no way of knowing when or what. I do believe that some very exciting science is about to demonstrated.