No it means that any subject to his in the Placebo side of the trial or the Controlled side of the trial...( subjects had the option to remain on their blinded assigned treatment arm**) the dash between the words Placebo and controlled means both sides... my guess is that most of them came from the controlled side, because they are still in chemotherapy and the treatment is working for them and dont want to stop taking it. The market, retail side of it, is reacting to the delay and not paying attention to the fact that people want to continue.
If the Crofelemer was not working then who would want to continue why keep taking a pill and continue to have diarrhea. And these folks had to have moved over to stage II a while ago since it also states in the PR that the stage II is completed and is now being evaluated.
Stage II of the trial has concluded. Inclusion of Stage I data and Stage II data, with success, is required in the supplemental NDA filing * of crofelemer to add the indication for prophylaxis of diarrhea in cancer patients receiving targeted therapy with or without standard chemotherapy.
People are knee jerking and at these prices its a steal, I am looking at this as if the idiots at Jaguar never gave the before Thanksgiving time line...that was a major blunder on their part... it should be viewed as if they are saying for the first time Phase III results will be released during the 1st quarter of 2024
*New Drug Application or FDA approval
** They would continue to get either a placebo or Crofelemet pill for stage II...
