I think it's odd, that four weeks ago today....RGRX put out a "shareholders letter", out of the blue...but they never once mentioned the EB trial or it's apparent very good result. why? I think RGRX had the results in hand before they did the May 13 letter. So why not mention it? I think the FDA had the data too...the FDA just isn't that efficient (is anyone in Gov't?) that they would get trial results up instantly.
So what gives? Why didn't RGRX mention it? Why aren't they mentioning it now? We all know about it. What worries me is that they might have to scrap the whole EB trial....even tho' we may have healed 8 of 22 (unheard of in EB).........because the trial is called into quetion for it's validity.....because of the placebo response as well. If that is the case, then RGRX would shut up about it and never speak of EB again...is that what they are doing? Shame....if TB 4 finally worked, in a very bad child's disease......and aother RGRX trial screw up (AGAIN).....invalidates it..... the trial cannot be replicated - as it took from 2006 to 2013 to do this one..and RGRX is all but broke.... WHAT'S UP RGRX???
Hey sno, you don't like my little theory on placebo #'s?
We know little actually of trial. How many got each doze and what is response rate? How severe was each case of EB? Partial response rate?
And breaking down results above would not take any more time or money. RGRX chooses not to release. Why?
RGRX must release trial results via PR on newswire. No other bio has ever not done so. Is rgrx colluding with short to keep price low? Fink had better wake up and start working for shareholders; and I am not talking about some stupid letter to shareholders.
I dunno, bo..... we all know that the FDA is a stcikler on trial protocol. They may throw the whole trial out because of the placebo water gel response....because the FDA and every EB sufferer & parent & Doctor.....knows that a water gel placebo won't do a damn thing on an EB blister - except make it moist. Data is not legit???
It was such a LOOOONG trial......2006 till now results - in 2013....that it is possible there was some crossover to TB 4. If there was crossover, then the 5 placebo ones could have been TB 4 ones....which means 13 of 25 were healed.......complelely. And I bet others were healed partially. If so, that makes TB 4 close to a miracle drug for EB sufferers. And no safety or side effects either.
RGRX is SILENT on EB for a reason.....that is what scares me most. They might not mention it because the results in placebo call into question the validity of how trial was done in first place? And teh FDA refuses it?? We know RGRX screws up trials easily.(like dosing all but unhealable Stage 4 ulcers in pressure ulcer trial) That is the curse of Thymosins.....happened w/ TA-1 too.