Many thanks for this reply.
> Yes, SA, with the help of David Welch is paving the road so we can operate.
> I'd agree. These are the prices to load up on if you can and like Goosebumps says, they won't be around for long.
> That's an awesome, well thought out educated guess thinking 4Good folks as major investor. Applause!
> Never really thought about hospitals.
> Thank you for siding with Kelly and Recknor and on their decisions. SK gave some hints about the histocytes and the cells doing the scarring containing CCR5 and alluded to that as MOA. and Recknor kicking ass with MRI markers of cT1 and PDFF which will probably be revealing an unmatchable upheaval in NASH treatment.
> Yup, XYZ being stated here:
> Nader seemed so positive about 10 days prior to that CC, when it was cancelled the day prior I think. And then he was let go a few weeks later. Very likely that it was all decided then. After we are approved, and have solid partnerships, someone needs to put it all in writing.
> I'd agree with the 2 new board members. You are referring to:
> I think CEO MUST be very carefully chosen with clean history, sharp background, decent credentials, wit, ambition, having virtue. Prior experience and connection to Big Pharma in any way shape or form, would be a plus leading to connection to that world. I think it will take more time than that.
> any thoughts on who might step down to free that seat?
> I very much appreciate your thinking! Thank you for reaching out forward.
> Yes, SA, with the help of David Welch is paving the road so we can operate.
> I'd agree. These are the prices to load up on if you can and like Goosebumps says, they won't be around for long.
> That's an awesome, well thought out educated guess thinking 4Good folks as major investor. Applause!
> Never really thought about hospitals.
> Thank you for siding with Kelly and Recknor and on their decisions. SK gave some hints about the histocytes and the cells doing the scarring containing CCR5 and alluded to that as MOA. and Recknor kicking ass with MRI markers of cT1 and PDFF which will probably be revealing an unmatchable upheaval in NASH treatment.
> Yup, XYZ being stated here:
Quote:Scott Kelly 9:00: 2 cardiac events led to pausing CD16. they don't know if these patients are LL or placebo. They want to pause the trial b/c our experience w/LL was in healthy volunteers and not in critically ill Covid 19 population of sick individuals. They have a preplanned DSMC meeting data safety monitoring committee in early April for both studies. So upon clearance of the DSMC we plan on removing the pause. We are in communication with ANVISA and the FDA and reported the events to each agency, but this was CytoDyn's decision. Full clinical hold on US IND Covid 19, and partial clinical hold for IND for HIV. The FDA wants aggregated safety data across all indications as our prior CRO was not aggregating safety data. We will correct this. We believe this is a solvable problem. We have contracted with a new pharmaco-vigilance CRO to move forward. So we expect about an 8-12 week, (June-July 2022), timeline and seek advice from the FDA.
Chris Recknor11:25: Re-evaluation of the BLA timelines, we will have a delay in the clinical activities for the BLA while we are performing the pharmaco-vigilance evaluations through the new contracted CRO. Bond was posted with Amerex, and data was obtained for all of our trials, including trial master file, and we will use this to move the BLA forward. On NASH, we completed Phase 2a for NASH during 2021, and announced preliminary results in January, we are in process of conducting final analysis of the data and plan to release the updated trial results in the near future and we are real excited about these results of this trial including the MRI findings the pdff and ct1 as well as biomarker data. No approved drug for NASH and liver disease is the leading cause of death in HIV patients. They are looking for partners.
> Nader seemed so positive about 10 days prior to that CC, when it was cancelled the day prior I think. And then he was let go a few weeks later. Very likely that it was all decided then. After we are approved, and have solid partnerships, someone needs to put it all in writing.
> I'd agree with the 2 new board members. You are referring to:
Quote:The board is also actively working to identify a financial expert as well as additional individuals capital markets & FDA regulatory expertise. The board has formed a CEO search committee working with 2 executive search firms as well as with corporate partners, to source and identify a CEO candidate. They are excited about the candidate pool.
> I think CEO MUST be very carefully chosen with clean history, sharp background, decent credentials, wit, ambition, having virtue. Prior experience and connection to Big Pharma in any way shape or form, would be a plus leading to connection to that world. I think it will take more time than that.
> any thoughts on who might step down to free that seat?
> I very much appreciate your thinking! Thank you for reaching out forward.
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