Frank wrote:Does anyone know how they are getting funding for the phase-III trial.
I mean after the IIb trial there was much disappointment and the therapeutic concept itself was taken to question. What changed since then? Did they change the therapeutic concept in some way, do the only recruit a certain typ of patients for the phase-III as opposed to the IIb trial? And again who is giving them the money for a very costly (Phase-III is reported to be a multi 100million US$ project) after a "failed" Phase-IIb trial!?
Phase II-b didn't "fail." The cash dried up after the Moron Brigade assed around with a mid-phase report (it doesn't take a rocket scientist to know that Money People never read beyond the first sentence). So with the positive results buried in the final paragraphs, OF COURSE it was inevitable that support would dry up.
If the therapeutic concept had been a total bust, Phase I results would have halted even the recruitment for our Phase II. And Phase I demonstrated some extremely impressive data.
Yip, Phase III is going to cost a boat-load of cash, no doubt about it. I have no idea how many Opexa staff are figured into the treatment of one patient but if Phase III follows the typical 5,000-person protocol, this might be a good time to apply for lab tech job if you live in the Houston area.
There will be so many more sites, too, and that's a cash outlay. Lotsa bucks.
Now about the "inclusion protocol," last I heard Phase III will cut across the "ambulatory" restriction on Phase II. Since it wasn't an exclusion during Phase I, I kinda wondered why it was so during our phase.
Let's see. Oh yes, the rumor also hinted that "Progressive" patients would be included as well as us "Remitting/Relapsing."
As far as I can guess, the only exclusion will be the failure to pop up those Myelin Reactive T-cells.
Which can be only good news for all of us.
However, I do intend to request the firing of whatever moron wrote up that damned damaging report.