"In respect to the "Clinical Trails" info:"The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo"
You are confused. RGRX is able to say anything they want, when they want, on the EB trial. There is NO up to 60 day embargo. What that refers to is the DOCTORS, or the "Principal Investigators" - called "PI"....who actually dosed & oversaw the EB children. The restriction is that the DOCTORS (PI's) are restrictd for up to 60 days of "publishing" the EB results first (before RGRX), and the SPONSOR (RGRX) has right to review what the PI writes. the SPONSOR (RGRX) controls for 60 days what releases are done. After 60 days the PI can talk of it. There is NOTHING AT ALL stopping RGRX from doing a press release right now on the EB trial.......nothing. But I do not think RGRX will do so. Because people will think the trial failed. Even tho' TB 4 healed 8 of 22 (or 35%).....the water gel placebo healed 5 of 8 (or 60%). So it looks like placebo healed TWICE as good as TB 4. But we all know that water placebo jelly won't heal EB, otherwise EVERY EB child would use water jelly, and they are cured, So the trial, once again for RGRX, is F'ed up.
You still are confused. That 60 day thing you keep harping on has NOTHING to do with RGRX. RGRX is able to talk about the EB trial anytime, anywhere they want to. The 60 day restrictions ONLY pertain to the INVESTIGATOR DOCTOR in the EB trial. It is THEY who have the "up to 60 days restriction on disclosure", NOT RGRX. That was put in so the Investigator doctors didn't release info BEFORE RGRX would.
RGRX can do a PR anytime they want to. There is NO 60 day wait!