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Scarlet_Periwinkle

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November 26, 2024 8:48 am

Dear Mr. President, My heart goes out to you during this difficult time. In my opinion, you are doing a great job against fearfull odds that would crush a lesser man. I don't quite know how to start... View MoreDear Mr. President, My heart goes out to you during this difficult time. In my opinion, you are doing a great job against fearfull odds that would crush a lesser man. I don't quite know how to start this and I won't know exactlly how to end it so I just get right to the middle. I have been fighting my own personal "Convalescent Plasma" battle here in REDACTED since 8 February with unknown success. Basically I have been poking at people with the local plasma center, one of the local hospital systems, the vice-president of the local city council and even you (e-mail thru the White House "contact us" site on or about 18 March) telling folks that all H*ll was fixing to break loose and a plan needed to be in place when Convalescent Plasma Donors (CPD) became widely available. It did my heart good several days ago when I saw that the FDA had moved on CP for the emergency treatment of the seriously ill. Looking at the numbers, over the next several days, potential CPD's, as defined by the FDA: https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds as estimated by this observer, are set to increase from under 200 to just under 900. (We should be at almost 6000 potential CD donors nationwide including 42 military by 15 April) The difficulty I see is that everything I have seen on Fox News is showing whole blood. I consider this a massive waste of resourses because once a CPD donates a unit of blood, helping one person, the CPD is out of the fight for 8 weeks. With Commercial Plasma, the CPD can donate approximately 2 units of plasma twice a week. Over the course of the 8 weeks that the whole blood CPD is sidelined, the commercial plasma CPD has helped an estimated 64 people. (estimate based on being able to get 1/2 unit of plasma from a unit of whole blood). ..... Now would be a good time to send Dr Fauci, bless his heart, out on his daily run. Along with CP being used as a therapy, it also has a very strong potential of providing Tempory Passive Immunity for a period to an uninfected person who is at risk. This is what I have been thinking about since early February. The use of CP immunization to protect our health care professionals, part of a larger REDACTED Unified Model, Profalactic and Sustained Therapeutic Epidemiological Response, Fighting Imminent Regional Emergences. Things have progressed. Now we have the situation with the Teddy R. off of Guam. In a nutshell, extreme circumstance requires extreme response. Perhaps it is time to get Commercial Plasma into the fight. My proposal is for you to recruit a couple of hundred potential CPD's to come to REDACTED (we're just on the brink but it is still quiet) to provide profalactic CP to an emergency team of Nuclear rated Officers and Seamen (best if they have served on the TR) and a Navy surgeon who will be routed thru REDACTED for innoculation in route to the TR to secure her reactors. Thereafter CPD's will be rolled into a trial referenced above (DUMPSTERFIRE) involving the healthcare providers with REDACTED's two hospital systems until such time as they can be replaced with local donors. (approximately day 60 on a log(1.15 ) curve.) (REDACTED is on about day 12 as I write this) By this time, sufficient time should have elapsed to compare the curves representing rates of infection in REDACTED to rates of infection just about everywhere else to see if we are getting the desired results (the old throw it against the wall and see if it sticks protocol). If the curves are good, REDACTED will be in a positioned to assist other areas of the country and at Max Plasma (estimated 1800 certified donors and day 81 on a log(1.15) curve) REDACTED would be able to provide CP (Approximately 2400 1/2 unit immunizations per day) and become a force multiplier for the health care community ........ (and perhaps reduce the need for PPE to pre-CV-19 levels) or to immunize the entire crew of a CVN in about 2 days should the need arise. And CSL probably has more than 100 plasma centers nationwide in addition to a couple of other Commercial Plasma companies. Dumpsterfire will also give a bit of cover to how the Teddy R situation is addressed. We have to entertain the possibility that Covid-19 is actually a test of Pandademic 3 which got out of control and that there are those watching how we respond. To make this happen, you'll also need to handle the FDA and CDC about any issues of a Source Plasma company working directly with local hospitals, emergency waivers of the requirements of 21CFR6xx and such. There are many details to work out but I'm ready to do what I can at this end. Just say the word go. (And perhaps a short video attachment to an e-mail for me to use as credentials, the old "please provide every courtesy and cooperation" type of thing.) My contact information is: REDACTED REDACTED REDACTED REDACTED REDACTED _______________ Local contact information for CLS Plasma-REDACTED would be: REDACTED (Clinic Manager) or REDACTED (Specialty Product Coordinator) REDACTED REDACTED@cslplasma.com They will be able to give you their corporate information so you can smooth things over. If you talk to them, there is no need to identify me as your emissary, just add a request for a cup of coffee and a half dozen doughnuts to the "every courtesy and cooperation". They will know exactly who to be annoyed at and hey, these days we take our fun where we can get it. CSL Website: https://www.cslplasma.com/ ____________ Once DUMPSTERFIRE starts we can bring in : REDAACTED, MD Infectious Diseases REDACTED Hospital REDACTED He has not answered my call asking for information but hopefully he is thinking. He will be able to provide information for his counterpart at REDACTED .............. _______________ Finally, since I have not had a response to my e-mail of 18 March, and because I feel that the situation is becoming more urgent each day, I'm going to attach it, along with my earlier efforts, to an e-mail to Mr. REDACTED with a request that he get it to you. Based on what I am seeing, I think it prudent to plan on this to go to 50% saturation before the curves start reaching their apex. Flattening the curves serves only to delay that event and relieve pressure on the health care system. (Very important) In closing, I would again commend you for the fantastic job you are doing. Sincerely yours and ready for the fight. REDACTED Oh, I guess you had better let Dr. Fauci back in.

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Investigational COVID-19 Convalescent Plasma - Emergency INDs

www.fda.gov

FDA is providing updated information to health care providers about pathways available for administering or studying the use of COVID-19 convalescent plasma

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