RE: The engines are starting ....8 Nov 2023 15:19
Ok I will bite.
Correct HT, NONE OF US know, yet we have trolls on here acting like subject matter experts telling us about what does or does not need done and going so far off into the land of opinion, theory and hearsay that its getting ridiculous.
The ONLY people who know if Hemo can overcome the CH are Hemogenyx, Prevail and those in the ORIGINAL team at the FDA.
Hemogenyx GUESSED the issue BEFORE the FDA confirmed it to them and begun working on a fix. They then implemented this fix and produced lab results to prove IN a LAB environment that the solution worked. These test results and an overall plan were submitted to the FDA who have APPROVED the plan + accepted the results.
Probably the same tests needed validated off sight in a clinical certified environment, this does not change WHAT is being tested. As for additional work? Well part of that was to appoint Prevail to manage the clinical tests, what else is required??? I dont know, HH does not know, Stu does not know, 121 does not know, MrIndia does not know.... But guess who DOES know?
The FDA - Who approved the plan based on results submitted
Hemogenyx - Who stated in a regulatory publication that they envisaged having this hold lifted allowing trials to start IN 2023
Prevail - Who have a proven track record of running clinical trials quicky, efficiently with rapid feedback, so much so that they are pretty much doing this work on faith as they are being paid in shares.
Now if people would quit guessing, making sh17 up and READ the RNS's which are right there that would be just swell.