What I meant is that there has been some thought about A273 getting (provisional) approval based on signs of patients, care givers and the health care system... is what I do not believe. I thought you meant that too.
The only way anavex will get approval is by delivering statistical evidence it works.
You must also consider the provision or RWE and RWD and allow for the conversion of these (signs) to data, facts and statistical modeling of these events. (see the recent post from Xena on this conversion/topic as evidence of the science). See science, clinical facts and data/information/knowledge on sleep for example.
Provisional approvals based on these kinds of facts are possible such will be shown in most EHR, when done correctly. Which is probably why the FDA and other regulatory bodies have created the definitions and guidance docs/rules for use.
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