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Posted On: 03/24/2021 3:11:37 PM
Post# of 149742
Per that FDA SRO comment. Looks like HGEN and cydy both on that list. Rlftf is notably absent, apparently fda doesn't care about them yet.
Relistened to the CC as I was kinda multi-tasking first time around. A couple nuggets I missed.
NP said FDA had no problem with them submitting cd16 and cd17 meaning, they didn't shut them down so clearly the FDA saw some value in the results. Not holding out hope for conditional EUA but would welcome it. Also noted the question about dsmc for cd16, NP said they will do an interim and IF they hit a statistically significant value at interim the UK said that's good enough for them and "most likely US fda as well".
Also apparently some deal in the works to provide someone else leronlimab to trial something. Dr Kelly said he can't get into specifics until things are agreed to or something of that nature. So would be interesting to see what name would be linked to ours in the press release should this trial come about. But it sounds like the negotiations and contract write up are happening. Gotta keep Dr Brendan Rae busy, he's been relaxing too much after the vyera deal.
Relistened to the CC as I was kinda multi-tasking first time around. A couple nuggets I missed.
NP said FDA had no problem with them submitting cd16 and cd17 meaning, they didn't shut them down so clearly the FDA saw some value in the results. Not holding out hope for conditional EUA but would welcome it. Also noted the question about dsmc for cd16, NP said they will do an interim and IF they hit a statistically significant value at interim the UK said that's good enough for them and "most likely US fda as well".
Also apparently some deal in the works to provide someone else leronlimab to trial something. Dr Kelly said he can't get into specifics until things are agreed to or something of that nature. So would be interesting to see what name would be linked to ours in the press release should this trial come about. But it sounds like the negotiations and contract write up are happening. Gotta keep Dr Brendan Rae busy, he's been relaxing too much after the vyera deal.
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