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Posted On: 12/27/2020 10:57:12 PM
Post# of 153940
“In my mind this makes a world of difference, and supports my theory that the FDA has an inclination of our efficacy.”
If your “source” is legitimate and NP is being truthful, the FDA likely reached out in an effort to reduce the EIND burden on trial site doctors and the FDA. EINDs will still have to be filed from non-trial sites.
In regards the FDA having any inclination to the status of the trial, IMO, based on the FDA’s guidelines for trials and DSMCs, the FDA has not seen the data. In the FDAs guidance regarding DSMCs, they state the FDA rarely interferes with the data of ongoing trials in order to, “minimize the possibility of jeopardizing the integrity of the ongoing trial.“ if the FDA has looked at the data and knows the primary endpoint will reach its goal, they would likely recommend much more than just continuing EINDs and an open label extension.
If your “source” is legitimate and NP is being truthful, the FDA likely reached out in an effort to reduce the EIND burden on trial site doctors and the FDA. EINDs will still have to be filed from non-trial sites.
In regards the FDA having any inclination to the status of the trial, IMO, based on the FDA’s guidelines for trials and DSMCs, the FDA has not seen the data. In the FDAs guidance regarding DSMCs, they state the FDA rarely interferes with the data of ongoing trials in order to, “minimize the possibility of jeopardizing the integrity of the ongoing trial.“ if the FDA has looked at the data and knows the primary endpoint will reach its goal, they would likely recommend much more than just continuing EINDs and an open label extension.
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