FDA open label extension requires that the doctor,
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Posted On: 12/26/2020 5:15:51 PM
FDA open label extension requires that the doctor, according to a check list, access the patient as qualifying to receive leronlimab, however, these are only doctors at leronlimab s/c trial sites. And that patient is added to the trial, and will 100% receive leronlimab, no more placebo being given. No long paperwork plus "wait" for FDA giving the OK to give LL shots.
Doctors not at trial sites, must go the eIND route with paperwork and, a wait for the FDA to evaluate the patients's application, and approve for each individual patient.
Most folks seem to believe the open label extension, indicates a high probability the the FDA will be granting leronlimab an EUA. Others disagree.
If the FDA has in fact, not seen the Phase III s/c data, maybe the DSMC
(who has stated they are doing a "rolling" observation of the data)
maybe the DSMC has given hints to the FDA regarding the strong efficacy.
Doctors not at trial sites, must go the eIND route with paperwork and, a wait for the FDA to evaluate the patients's application, and approve for each individual patient.
Most folks seem to believe the open label extension, indicates a high probability the the FDA will be granting leronlimab an EUA. Others disagree.
If the FDA has in fact, not seen the Phase III s/c data, maybe the DSMC
(who has stated they are doing a "rolling" observation of the data)
maybe the DSMC has given hints to the FDA regarding the strong efficacy.
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