I enjoy these interviews because they give us shareholders information one way or another (positive and/or negative).
Wanted to cite Nader on his own words:
This was important, so we have one day to re-adjust our positions as maybe Tuesday will be too late.
So, one of Nader "cards" is obtaining Unmet Medical Need for Leronlimab for M-M.
This is also, critical. CYDY's plan has been to reinforce the M-M with the S-C and viceversa. Is a double-whammy technique. If the S-C comes very good, how can FDA "forget" about the M-M (the message: the drug works !!)?? In retrospective, I remember that they have been trying to synchronize both trials results. This is the reason.
Yup it is, you are welcome.
In relation with Dr. Patterson is obvious that something has changed. imo four thing might have happened:
• Price (very expensive as NP seem to imply)
• Conflicts of Interest (can't be shareholder and conduct the tests)
• Processing capability (There where lots of tests that needed to be carried out. At some point BP said they where working 24/7 with three shifts.
• Something else went wrong. Differences on timelines, test methodologies, payment methods, personnel levels.
Next few days will be very important. The P2 for opener and, then, the S-C P3 evaluation that could potentially end up in out first approval.
Wanted to cite Nader on his own words:
Quote:During this weekend Amarex is working very hard to have those results and I am hopping on having those results on Monday and have a press result on Tuesday.
This was important, so we have one day to re-adjust our positions as maybe Tuesday will be too late.
Quote:I have a lot of enthusiasm about the data from day one. Why ? Because as somebody people says: anecdotal don’t come out of ECMO.
Quote:If we get M-M results to be very successful, then we will be telling the FDA here is the results:” would you be approving us or you would be giving us give us a P3. Pandemic or not FDA has the rules about Unmet Medical need population.
So, one of Nader "cards" is obtaining Unmet Medical Need for Leronlimab for M-M.
Quote:We articulated to have a look at the results of S/C at the same time to be able to give FDA some results so they can make a decision can we make an exception and make emergency approval immediately or there is something else we need to do.
This is also, critical. CYDY's plan has been to reinforce the M-M with the S-C and viceversa. Is a double-whammy technique. If the S-C comes very good, how can FDA "forget" about the M-M (the message: the drug works !!)?? In retrospective, I remember that they have been trying to synchronize both trials results. This is the reason.
Quote:Is a beautiful situation for CytoDyn shareholders. Can’t thank them enough for hanging in there.
Yup it is, you are welcome.
Quote:As we said before optimism is through the roof. You have to hold me up.
Quote:If we get beautiful results right now I think the whole world will pay attention.
Quote:We have a product that that we believe it can help in multiple segments of this population, will have to just brake first barrier and get approval and everything will fall in place.
Quote:I am trying to get the best bang for the shareholder’s buck.
Quote:We love Dr. Patterson; we have no problem with him. We just have to carry on business and go forward.
.Quote:Dr. Patterson’s Ted-X was fantastic. I love Dr. Patterson. Dr. Patterson is great man. He has done lab work for us, whether we agree or disagree on some path going forward it has nothing to do in my feelings for Dr. Patterson. We made sure that Dr. Patterson is, happy hopefully, with us, with the contract(s) that we signed
In relation with Dr. Patterson is obvious that something has changed. imo four thing might have happened:
• Price (very expensive as NP seem to imply)
• Conflicts of Interest (can't be shareholder and conduct the tests)
• Processing capability (There where lots of tests that needed to be carried out. At some point BP said they where working 24/7 with three shifts.
• Something else went wrong. Differences on timelines, test methodologies, payment methods, personnel levels.
Quote:I will be wearing that T-shirt starting Tuesday most probably.
Next few days will be very important. The P2 for opener and, then, the S-C P3 evaluation that could potentially end up in out first approval.
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