Tuesday, November 03, 2015 12:06:20 PM
The NIH announcement I believe lays the ground work for expanded access here in the US. It's difficult to know what form it will take, --- one could hope for the 17 experts wish, but I don't know. I imagine some sort of trial, using a sub-group, hopefully the NK Cell marker. the FDA wants more data, and they'll have to get it somehow. Who pays?...is my question - Hemispherx cannot afford to go it alone. Hopefully this is part of the NIH plan. The new NINDS (division ME/CFS is now in) director says they are going to move fairly quickly. My guess, end of this year or beginning of next for any ampligen news. Maybe we'll get a nice surprise for Christmas.
Other than that, I imagine we'll here about MERS orphan status from the EU soon.
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