While the future looks very bright for AEMD, we still have to wait a little longer, based on one of the lines from the "Thank you Shareholders" letter:
"We submitted an Investigational Device Exemption (IDE) to the FDA to request permission to initiate a clinical feasibility study HCV infected individuals who would be enrolled to receive Hemopurifier® therapy. We have since received comments and study design considerations back from FDA and are preparing a response that we hope will lead to the initiation of U.S. clinical studies."
We can only guess what those comments and study design considerations are, and hopefully they will be answered soon. FDA typically "stops the clock" after making such requests of a study sponsor and may or may not start the process over once a response is received.
While the IDE approval is important, I don't see it as a PPS mover. Unless of course we get news of a 'partner'. Was disappointed in today's release that there was no mention of the MD Anderson moonshot program scheduled to launch this month. That is the only near term catalyst I see to move us from this pathetic PPS base we are stuck on.
"since received comments and study design considerations", start uncorking slowly. Based on on what is known, we are finally moving forward, progress at last.
Patience is "Golden".
Good Luck to all the Longs, 14 years of waiting, JJ is happy now, we too shall be rewarded for our patience, however, after it is said and done, lives will be enriched on the medical front for many years to come.