This has been on my mind as well.
I believe the safety portion of the BLA that was already submitted contained the 50-patients from the 24-week CD03 at the 700mg dose.
Now, according to Kush Dhody, the FDA wants an integrated assessment of the CD03 for efficacy, safety, exposure related analysis, receptor occupancy, and one more metric that I cannot understand from the recording.
So, yes, why?
My understanding is as follows (correct me if I am mistaken):
We proved excellent Combo efficacy at a low dose of 350mg and they forced us to 700mg after the trial was over. Who does that? Seems like delay tactic to me.
They asked for, and we delivered, the 700mg Mono safety data earlier this year.
The additional data set that they are now asking for is from the CD03 Mono trial -- not a Combo trial. So why on earth do they need an integrated assessment of that entire data set -- when it largely has nothing to do with the Combo trial? I could almost understand wanting more data on safety and exposure related analysis, but why didn't they ask for this before? It sure seems to me that they are once again moving the goal posts on us.
Now, it would be one thing if the FDA was willing to take this new data and grant us a label extension for Mono (or whatever the terminology is) -- but I have been repeatedly told that we still have to do a P3 Mono Pivotal trial which is anticipated for later this year.
-- So, is this just another attempt to delay the Combo approval?
-- Or, more nefariously, is this sudden and last minute demand for more safety and exposure related data going to be used against us for COVID approval?
FDA: "Sorry, we can't approve COVID because you haven't submitted the safety data that we have asked for relating to the 700mg dose"
Or, four months from now ...
FDA: "Sorry, we still can't approve COVID because we haven't had a chance to review and process the additional 700mg dose data that you supplied two months ago"
Call me paranoid, but I don't have a good feeling about this.
I believe the safety portion of the BLA that was already submitted contained the 50-patients from the 24-week CD03 at the 700mg dose.
Now, according to Kush Dhody, the FDA wants an integrated assessment of the CD03 for efficacy, safety, exposure related analysis, receptor occupancy, and one more metric that I cannot understand from the recording.
So, yes, why?
My understanding is as follows (correct me if I am mistaken):
We proved excellent Combo efficacy at a low dose of 350mg and they forced us to 700mg after the trial was over. Who does that? Seems like delay tactic to me.
They asked for, and we delivered, the 700mg Mono safety data earlier this year.
The additional data set that they are now asking for is from the CD03 Mono trial -- not a Combo trial. So why on earth do they need an integrated assessment of that entire data set -- when it largely has nothing to do with the Combo trial? I could almost understand wanting more data on safety and exposure related analysis, but why didn't they ask for this before? It sure seems to me that they are once again moving the goal posts on us.
Now, it would be one thing if the FDA was willing to take this new data and grant us a label extension for Mono (or whatever the terminology is) -- but I have been repeatedly told that we still have to do a P3 Mono Pivotal trial which is anticipated for later this year.
-- So, is this just another attempt to delay the Combo approval?
-- Or, more nefariously, is this sudden and last minute demand for more safety and exposure related data going to be used against us for COVID approval?
FDA: "Sorry, we can't approve COVID because you haven't submitted the safety data that we have asked for relating to the 700mg dose"
Or, four months from now ...
FDA: "Sorry, we still can't approve COVID because we haven't had a chance to review and process the additional 700mg dose data that you supplied two months ago"
Call me paranoid, but I don't have a good feeling about this.
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