My personal reading of this announcement, "between the lines"
IN MY OPINION ONLY, FDA, liked results so far, were aware good news was coming. They advised PTX they need more patients to the study who, if they have similar responses, will result in expedited or fast tracked approval process/study processes. They are manufacturing more product to higher standards that will allow those on the FDA to support expedited progress if the other boxes are ticked
There is certainly success here, so topping up again.
And to the patients with complete responses, this is actually life changing. It also gives hope to those remaining on the trial. Very happy to back this horse
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- Ann: Continued promising results in PTX-100 TCL trial
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Ann: Continued promising results in PTX-100 TCL trial, page-6
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