Anavex Life Sciences Corp (AVXL)

[skitahoe]

I certainly don't know, but believe that the company has enough positive information to file and justify an approval that's either conditioned on a confirming trial, or by having the outcome of all uses reported in a Phase 4 to confirm the benefits and verify that no unknown detrimental problems are occurring. If the drug's also approved for AD or other diseases, they too could be part of the Phase 4, or it could be limited to only those treated for Rett's.

Personally I believe that the whole approval process ought to be simplified, costs and times reduced, but all approvals followed by Phase 4's that are easily inputted by the prescribing Dr. unless problems are noted, then they need to provide further information. If the FDA or others see specific problems developing, depending on the problem, they need to take action that may be as simple as a label change, or as serious as removing it from the market. Such actions should eliminate the possibility of drugmakers paying off patients to hide adverse reactions.

Gary