Cel Sci Corporation (CVM)

[frugalNorwegian]

I agree that handling it now is better than after the pre-BLA meeting. But I wish they didn't need to submit a "major follow-up packet" to the FDA. Maybe this is nothing and just part of the process with a new class of drug. But considering we are 15 months out and no pre-BLA meeting scheduled, I am concerned there is a bogeyman in the data somewhere. Regardless, I am still optimistic and the SH letter is a big reason for that.

Remember, when CVM announced their results, their first step was to reach out to the FDA and request a pre-BLA meeting. These are their words, not mine. That was in July of 2021. We still aren't there.

CVM will succeed with the data...or fail with the data. As Geert has always said, the data is key. I do want them to succeed...I really do. But I have to recognize this 15 month timeline to a pre-BLA meeting (and we're still not there) does not seem normal.