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djpope

09/11/17 6:51 PM

#15945 RE: hemopure36 #15944

I saw the 8k come out at the start of the conference and listened / viewed slides but the reality of the significance of the FDA designation for the Hemopurifer in the Expedited Access Pathway (EAP) Program really wasn't stressed or highlighted. Sounded just like it was submitted for "designation" but not yet fully accepted into the program. IMO JJ dropped the ball on this one and should have gone into detail what the designation actually means for the use of the hemopurifier and the benefits to the Company in Helping to move it ahead to full approval & marketing.

Maybe I missed something but I listened & it didn't convey as a Big Deal to me at the time but after reading details of the program I've come to think that it is. Plus the fact that 58k shares traded & it was up 25% to 1.998 all from 3:15 to 4:00 during & after the Rodman/Renshaw presentation today seems to agree that it is something substantial.

Any thoughts? TIA

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM393978.pdf