I PROFOUNDLY DISAGREE that statement is frought with assumptions...basically the assumption is that the data should be allowed to be entered under argument as the patient has used the product without following the directions on the label. NOPE INCORRECT
Typing in all caps does not make your erroneous contentions any less erroneous.
If patients in a phase-3 clinical trial don’t adhere to the protocol, it’s tough luck for the sponsor—the FDA does not give them a break because of what might have happened if patients had behaved differently. As far as the FDA is concerned, TDLP’s trial is a failure because the ITT data did not reach statistical significance. End of story.
It’s patently clear that you’re a neophyte biotech investor and all this is new information for you. Good luck with your TDLP investment.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”