Indeed the EIND is an ethical problem for the CD12 trial.
Indeed the EIND is an ethical problem for the CD12 trial. Are CD12 patients allowed to request an EIND?
This is obviously a severe ethical problem.
The FDA granted the LL EIND right upon the threshold of the last patient enrollment.
The FDA obviously weighed the ethical wrong of denying a handful of CD12 patients the choice between LL and placebo agains the ethical right of new EIND patients being saved.
Forcing the CD12 patients to take placebo is a very serious ethical wrong when the EIND option is available.
The ethical wrong of this FDA decision must have been balanced by some other weight which the FDA viewed more important.
Possibly the FDA believes that saving some patients is more important.
As part of the decision to reauthorize the EIND, the FDA must have planned for the situation in which a CD12 patient asks for an EIND.
If a CD12 patient asks for an EIND, to make sure they get LL and not placebo, the FDA must have decided to authorize the CD12 patients EIND.
In planning to grant CD12 EINDs, the FDA must simultaneously give Cytodyn a break on the statistics of CD12.
The FDA cannot grant a CD12 EIND without busting the CD12 trial, so my conclusion is that FDA plans to approve leronlimab.
I suppose there are other possible decision trees that the FDA could be using.
The FDA could simply deny CD12 patient EIND requests. But thats not going to turn out well.
The FDA could simply fill all CD12 patient EIND requests and adjust Cytodyn's required number of patients down from 390.
Seems to me a very serious calculus on the part of the FDA to permit EIND with CD12 still running.
There must be some precedent for FDA permission of EIND in a fatal disease with a placebo arm still running.
8
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