Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-1073

Yes but if the company is making these statements in an official capacity as announcements to the ASX made under the corporations act, while also making corroborating statements to journalists, then isn’t the most likely conclusion here that the company is simply misleading shareholders toward some unbeknown short term end? Or that maybe FDA has been scientifically kneecapped by “small pharma” in order to get a novel therapy for an unmet need over the line (even though pretty much all of the same people are still there)?

In saying this, if the above can be true I think it’s also possible that CYP may have inadvertentlybeen testing their bandaid on hands instead of feet in the DFU trial. I suspect it’s possible the investigators may be at risk of introducing confounding factors via appendage misidentification due to mistakenly treating hands that look like feet. This could well be exacerbated in cases where the investigators themselves may have hands for feet, or maybe feet for hands (hence the potential mixup and exacerbated risk of misidentification). The trial protocol doesn’t exactly, prescriptively and exhaustively spell out how the specific risk of hand vs foot appendage misidentification will be controlled for, and so think it may be a bit of a miss from an integrity standpoint and may ultimately be confounding, which is actually super sad for all holders cos it means the company will need to run another couple of trials.

None of you really deserve to have this spelled out for you, as my time is super valuable and you should all
really DYOR, but here’s an example of the type of participant that could really exacerbate the risk of appendage misidentification:

IMO my internet research largely supports my position.