What stuff from Dr Yang ?Dr. Otto Yang (UCLA), Dr.

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What stuff from Dr Yang ?

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Dr. Otto Yang (UCLA), Dr. Seethamraju (Montefiore), and likely others were on a call yesterday encouraging the FDA to relax enrollment requirements for the P3 S/C trial. Apparently, the call was successful.

Connecting the Dots

- As of today, 69 patients have been enrolled in this trial
- The first 51 patients will represent the interim results presented to the FDA
- The 51st patient was enrolled at the end of May
- If those doctors called the FDA yesterday to relax the enrollment requirements, then they would seem to be hedging against the possibility that the FDA will demand the results from the entire 390 patient sample size
- Alternatively, the call for relaxing the enrollment requirements might also be a means to save more people -- now that the EIND has been withdrawn by the FDA.

IMO