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Saturday, July 26, 2025 8:39:24 PM
Rapid use of the shelf or even use after LOQ responses sent in (and perhaps PR'd for SP reaction) but before CS2 would be a bad sign and SP would suffer.
I think your opinion is worth some thought. If a second clock stop is required in late October (assuming resumption of the first stop clock in late August), it would take at least until late December 2025-January 2026 to submit responses to the second LoQ with a CHMP adoption of opinion in late January 2026-March 2026. Therefore, under the two scenarios, AVXL would have at least until late October 2025 and perhaps until March 2026 to withdraw its MAA if, after seeing the second LoQ, AVXL decided it had reached the point of futility.
Therefore, AVXL has many months in which it can sit on the shelf registration without completing the $150 million financing. Since there is no urgency, the only reason I can understand for the early shelf filing is for potential leverage in partnership discussions and possibly, the opportunity to raise capital at a much higher stock price with highly favorable schizophrenia data. As you indicate, rapid use of the shelf might portend trouble with the application. I still maintain that Missling has a better than decent feel for the overall situation based on the nature of the first LoQ and the level of difficulty putting together adequate/convincing responses. We'll see--no one has a firm handle on what may or may not happen--it's a total guessing game.
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