Here is my take on the interview:
- Very professional rebuttal of the Citron paper. Kept it short and dismissed it.
- MM Trial: will have 87 patients vs. 75. Stopped last Wednesday June 24th. 2 weeks to finish dosing, July 8th. Hospitals have to enter their data, confirm it and sign off, then unblinding can occur. Perhaps by July 22nd? On schedule and larger number of patients bodes well..
- SC trial: currently have 120 patients enrolled!! Wow, this got accelerated. His comment on deaths was more a concern about the "sad" part of such tests where the placebo patients are more likely to be dying as they are not getting Leronlimab. If you truly believed in your medicine, this would be the view point of any compassionate person. As for unblinding in this trial, the protocol allows this to be done at the 50 patient threshold and then the stats would be computed based on these 50 patients. My read on his comment "if FDA allows..." was probably in reference to the desire to include more than 50 patients in the analysis since they are at 120 patients enrolled already. This could help Leronlimab for a better 'p' value but he is not sure they would accommodate that.
- DISTRIBUTION: As NP said, post approval, getting the distribution would be the next bottle neck. His words, "GAME CHANGER," if the distributor he is going to sign up gets done! His words " A VERY WELL KNOWN PHARMA..." along with a big smile. We will know latest by MONDAY, maybe sooner!!!!!
- TIMOTHY BROWN the mystery HIV cured patient due to a bone marrow transplant in the UK .... Dr, Jonas Sacha (as I understand), based on his animal testing, thinks ithe cure can be replicated using Leronlimab which mimics (?) the genetic mutation that results in the loss of CCR5 in certain subsets of HIV infected patients. These HIV patients, when they undergo a bone transplant due to cancer, can now be potentially "cured of HIV!" WOW!! 10-15% of HIV patients due to cancer or other illnesses need bone marrow transplants.
- They have 2 patients ready to undergo this bone marrow treatment with Leronlimab, and if successful, they will file for a BTD immediately!!! Sorry, but I am getting overwhelmed with the potential of this miracle monoclonal antibody.
SO I AM THRILLED WITH THE INFO WE RECEIVED FROM Dr. NP TODAY.
- Very professional rebuttal of the Citron paper. Kept it short and dismissed it.
- MM Trial: will have 87 patients vs. 75. Stopped last Wednesday June 24th. 2 weeks to finish dosing, July 8th. Hospitals have to enter their data, confirm it and sign off, then unblinding can occur. Perhaps by July 22nd? On schedule and larger number of patients bodes well..
- SC trial: currently have 120 patients enrolled!! Wow, this got accelerated. His comment on deaths was more a concern about the "sad" part of such tests where the placebo patients are more likely to be dying as they are not getting Leronlimab. If you truly believed in your medicine, this would be the view point of any compassionate person. As for unblinding in this trial, the protocol allows this to be done at the 50 patient threshold and then the stats would be computed based on these 50 patients. My read on his comment "if FDA allows..." was probably in reference to the desire to include more than 50 patients in the analysis since they are at 120 patients enrolled already. This could help Leronlimab for a better 'p' value but he is not sure they would accommodate that.
- DISTRIBUTION: As NP said, post approval, getting the distribution would be the next bottle neck. His words, "GAME CHANGER," if the distributor he is going to sign up gets done! His words " A VERY WELL KNOWN PHARMA..." along with a big smile. We will know latest by MONDAY, maybe sooner!!!!!
- TIMOTHY BROWN the mystery HIV cured patient due to a bone marrow transplant in the UK .... Dr, Jonas Sacha (as I understand), based on his animal testing, thinks ithe cure can be replicated using Leronlimab which mimics (?) the genetic mutation that results in the loss of CCR5 in certain subsets of HIV infected patients. These HIV patients, when they undergo a bone transplant due to cancer, can now be potentially "cured of HIV!" WOW!! 10-15% of HIV patients due to cancer or other illnesses need bone marrow transplants.
- They have 2 patients ready to undergo this bone marrow treatment with Leronlimab, and if successful, they will file for a BTD immediately!!! Sorry, but I am getting overwhelmed with the potential of this miracle monoclonal antibody.
SO I AM THRILLED WITH THE INFO WE RECEIVED FROM Dr. NP TODAY.
13
1
