@BullriderNkg Although I think it’s unlikely, the option of deliberately not filing an FDA application is still on the table. $CMRX did file an application for an investigational drug that had completed Phase 3 trials, but later withdrew it. Shortly thereafter, it was acquired by $JAZZ, which filed the application and successfully obtained approval. It goes without saying that major pharmaceutical companies have far more experience with FDA submissions, making mistakes less likely and resulting in a higher approval rate ($UNCY received a CRL due to a minor error).
previous $CMRX withdrew its application for early approval before it was acquired.We thought it was bad news, but later found out that CMRX withdrew its application because it had decided to be acquired behind the scenes.We believe that such an application is closely tied to the acquisition.
$CMRX Is this board closed? ONC201 Dordaviprone granted accelerated approval for diffuse midline glioma. $JAZZ stole Chimerix for peanuts, $8.55 per share/$935M was and still is a joke. I never cared for the Mike who spent his days riding around the Indiana countryside because of what I perceived as an inflated ego, and sadly it seems the other Mike (who I did like) was influenced to sell way to cheap. It is too late now but at least there is a life saving treatment for children who have few options. Just my opinion. congrats to the dedicated Chimerix employees for getting this across the finish line. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma
Just for nostalgia sake:
TODAY Jazz Pharmaceuticals Announces U.S. FDA Approval of Modeyso™ (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma $JAZZ $CMRX
Interesting to compare vs $DAWN Day One (we are long) $IPSEY Ipsen partnered.
$INAB “The global glioblastoma multiforme (GBM) treatment market is projected to grow significantly, reaching an estimated $5.7 billion by 2033. This growth is driven by factors like the rising incidence of GBM, an aging population, and the development of new, more targeted therapies.”
Major companies involved in GBM treatment include $BAYRY Bayer, $MRK, $CMRX Chimerix, Aivita Biomedical, Denovo Biopharma, $BMY Bristol Myers Squibb
