Replies to post #481178 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

EMA accepts an MAA on being complete with valid contents. That does not make the data contained 'sufficient' for approval. If it did then why have a long deep review after with clock stop questions.

Refer to one of my prevision posts and this conclusion.

Conclusion: Does the Overall EMA Approval Rate Provide a Good Estimate?
While overall EMA approval rates (e.g., 85% of accepted filings) are encouraging, they cannot accurately predict Anavex’s chances because:

The complexity and high-stakes nature of AD make approval more challenging.
Averages do not reflect the individual strengths or weaknesses of a specific submission.
A valid estimate requires detailed consideration of Anavex’s clinical trial data, the regulatory landscape for AD, and historical approval patterns for similar therapies. Until detailed EMA feedback is available, only a cautious optimism based on the strength of submitted data is warranted.

[williamssc]

After several meetings and seeing full data, the EMA requested Missling and company apply for full approval.

[boi568]

The EMA clearly was not bothered by the lack of a second trial. Why else would it then devote its time and resources to a year long and broader review of blarcamesine when it was doomed to be rejected for such an obvious fatal flaw? How could it achieve such a high approval MAA approval rate if its acceptance standards were so low? Again, too stupid to imagine.

I have noticed that as the facts have turned more and more favorable for longs, Investor's and other's predictions of certain doom have become ludicrous.