I found this: This is of more significance to our Israel-cure story..
As the FDA was prepping to allow emergency use of blood plasma donation from recovered COVID-19 patients, government officials have put pay to that.
The authorization is on hold for now as more data are reviewed, and H. Clifford Lane, M.D., clinical director at the National Institute of Allergy and Infectious Diseases, said an emergency approval could still be issued in the near future, as quoted by The New York Times.
This comes after National Institutes of Health leader Francis Collins, M.D., and COVID-19 response leader Anthony Fauci, M.D., recently questioned how efficacious treatments from it could be.
It has been touted as a potential treatment by President Donald Trump, but leading scientists want to see more data and robust testing to see whether this is borne out.
The idea is to take blood from those who have had the disease and successfully fought it off; in theory, they should have a high level of antibodies (and the more recent and more ill a patient was appears to be the better for it) that can be used in sick patients struggling to battle the disease.
Essentially, it is using someone else’s antibodies to try to attack the virus in those who haven’t made them, or made enough. But the data on whether this can actually help have been mixed, and studies not always well conducted, leading to questions over how well it can help some of the sickest patients and how well trials into assessing this are being done.
“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” said Lane in an NYT interview.
The FDA declined to comment on the story./ / /
Recently Kamada(NASDAQ, TASE:KMDA) completed manufacturing of the first batch of its plasma-derived immunoglobulin (IgG) product for the treatment of COVID-19 and the initial vials are available for compassionate use
in Israel.
So now we have a situation. patients walking out of Hospitals in Israel... but they are using American collected blood... is this still allowed?
In addition, Kamada submitted a proposed clinical protocol for a Phase 1/2 clinical trial of its IgG product to the Israeli Ministry of Health, and the company expects to initiate the study during the third quarter of 2020.
In order to expand its clinical development program to the U.S., Kamada, with the support of Kedrion Biopharma, intends to conduct a pre-IND meeting with the FDA early in the third quarter in order to obtain FDA’s acceptance of a proposed clinical development program.
Kedrion also is currently collecting COVID-19 convalescent plasma from U.S. recovered patients that will be used by Kamada to manufacture additional batches of the product. Kedrion is collecting the plasma, through its plasma business unit, KEDPLASMA, at 23 FDA-approved centers across the U.S.
“To the best of our knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived IgG product for the treatment of COVID-19,” Amir London, CEO of Kamada, said in a statement./ / /
From what I read in the Q&A of their last earnings report-- I'd like to stick with KMDA. I think the FDA will come around. Better studies need to be done but they always say that I think they are more worried about the quality of the blood perhaps being collected. it is weird, there is more THC in my system than you could put in a Mack truck... But I may of had Covid.. Plasma anyone?
This is a good lesson though: you never know when the left hook is coming and the turnaround in policy here by the FDA is troubling but does not mean that the premise is entirely wrong. I expect Israel to continue using this product & the art of the deal will be giving it to patients at the right time when they are most infectious...