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Re: Doc328 post# 506581

Monday, 11/10/2025 9:23:03 PM

Monday, November 10, 2025 9:23:03 PM

Post# of 519116

Cash plus schizo is worth 2.00 so can't go wrong with these.


Are you factoring in the $150 M ATM (or whatever portion already raised) and the Rett voucher (~$150 M) into that $2.00 per-share estimate?

For context, here’s the 2025 Oral Explanation (OE) record between January and July 2025:

Out of 15 total Pre-authorisation procedure oral explanations drugs,
8 that were already FDA-approved ? 100 % received a positive CHMP opinion,
7 that were not FDA-approved ? only 1 (˜ 14 %) received a positive CHMP opinion.



Drug (brand) CHMP outcome (100% CHMP positive - FDA approved Drugs)
--------------------------------------------------------------------------------------------------------------------------------------------------
Donanemab (Kisunla) | Initial negative (Mar 2025) ? Positive after re-exam (Jul 2025)
Vorasidenib (Voranigo) | Positive opinion (Jul 2025)
Givinostat (Duvyzat) | Positive opinion (Apr 2025)
Inavolisib (Itovebi) | Positive opinion (May 2025)
L-Acetylleucine (Aqneu | Positive opinion (Jul 2025)
Nirogacestat (Ogsiveo) | Positive opinion (Jun 2025)
Clascoterone (Winlevi) | Positive after re-examination (Aug 2025)
Deutetrabenazine | Positive opinion (Jun 2025)

Drug (brand) CHMP outcome (14% CHMP positive - Non-FDA approval Drugs)
--------------------------------------------------------------------------------------------------------------------------------------------------
Insulin human (Rechon) | Application withdrawn (Mar 2025)
Troriluzole | Application withdrawn (May 2025)
Atropine sulfate FGK | Negative opinion (May 2025)
Low-dose atropine | Positive opinion (Apr 2025) ? EC approval (Jun 2025)
Teriparatide Ascend | Application withdrawn (May 2025)
Resminostat (Kinselby) | Negative opinion (May 2025)
Pridopidine (Nurzigma) | Negative opinion (Jul 2025)

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