Hi All,
I requested my previous post be taken down as I realized there may have been an inaccuracy in it. However Clene did receive a 45 million grant and patients who did not qualify for the trial were allowed to receive their drug prior to approval, pending results. Here is some info on it.
https://www.cecildaily.com/news/clene-nanomedicine-wins-45-1-million-grant/article_e4e7770c-63a2-11ee-8877-c74c0ef60bd2.html
This part is correct however
Purpose of the GrantThe primary purpose of this grant is to enable ALS patients, particularly those who do not meet the criteria for clinical trials, to access CNM-Au8, which is currently under investigation but not yet FDA-approved. The EAP is a regulatory pathway that allows patients with serious or life-threatening diseases to receive experimental treatments outside of traditional clinical trials [[1]](https://www.pharmtech.com/view/nih-awards-45-1-million-grant-for-als-treatment).
Interesting the FDA declined to approve accelerated approval.
https://www.medscape.com/viewarticle/fda-denies-accelerated-approval-als-drug-2023a1000wdj?form=fpf
But there are many grants available to promising ALS drugs in the US. Just not sure if a non US company qualifies.
Cheers
Hi All, I requested my previous post be taken down as I realized...
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