Faron Pharmaceuticals - Innovatiivisia lääketieteen ratkaisuja (Osa 2)

Bono’s post. So, this is about the duration of CR (Complete Response). I wouldn’t be able to doubt its validity on any grounds, my bad. Why wasn’t it in the stock exchange release? Perhaps it wasn’t considered such significant information by anyone other than Bono.

The CRO (Contract Research Organization) matter comes up again. Faron has stated in a few stock exchange releases that it is preparing for Phase 3. “We will now focus on conducting the registrational Phase 2/3 trial for bexmarilimab in treatment-naïve patients with HR-MDS” In September, they publicly sought employees for, among other things, CRO collaboration. In the November investor presentation https://faron.com/wp-content/uploads/2025/11/Faron-non-confidential-corporate-deck-November-2025.pdf
it states “2025: CRO & key supplier selections for Phase
II/III BEXMAB-2 trial.”
Large trials cannot be conducted without a CRO.

IWG2023, which is used now and in the future, although Faron has also reported some responses according to IWG2006 in the summer?, (edit and now Phase 1/2 results) no longer has a 4-week limit, whereas 2006 does. A response is a response even if the patient dies the next day. Or if they went for a transplant, in which case the DoR (Duration of Response) would be 1 day, but these are likely censored in these non-randomized studies. OS (Overall Survival) is indeed continued.
In BEXMAB, bone marrow samples were taken every 3 months during longer follow-up, and blood tests apparently once a month. That also presents a source of inaccuracy. Is DoR considered to end on the same day when blasts attacked again, or 3/2, i.e., 1.5 months ago? Thus, when evaluating with IWG2023, DoR should be considered. If CR is long, good. If CR is a one-time measurement leading to transplant, good. A transplant guarantees at least as good OS as a long CR.

Edit. Faron does indeed report results according to IWG2006, or a small change came in 2018, because that criteria set was in use for Phase 1/2. Even if it is now known that responses according to IWG2023 would be more significant.

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