I can just imagine ecoool2 sitting at home, reading the comments...

I can just imagine ecoool2 sitting at home, reading the comments here, pulling his hair out at the drivel and rubbish being spewed (including by that particular thorn in ecoool2's sole...). And really, if there was ever a time when his insight and analysis would have been helpful? It's right now.

But ah, well. Glad I know why I am here and am ready for ANYTHING, including a thumbs down from the ODAC, forcing us to wait to see if the FDA ignores or accepts. Oh, and the COVID trial, as well. I am even ready for AGVHD getting knocked back. It's possible, even if unlikely.

What would really be satisfying if ODAC voted against approval would be for the interim readout on the trial for COVID to come out with BLOCKBUSTER results. That would really put the FDA--and ol' Trumpy--in a bind and throw some serious egg onto the faces of the ODAC members!

As to those ODAC members, I just cannot believe that they are doing this in complete isolation from all that is swirling around Ryoncil/Rem-L. If Ryoncil is deemed to be of questionable quality, so is Rem-L. That has to be weighing on their minds when they decide where to draw lines here, particularly where sleuthing here today has shown the line has been drawn lower for other treatments which have still been approved.

A NO vote due to manufacturing issues, concerns re: use of single-arm trials, etc., is NOT a good outcome in the middle of a pandemic in a country that NEEDS an effective treatment...and is full of anti-vaxxers who fear that Bill Gates has engineered this disease for his own nefarious purposes.