1. New procedure through blood purification is said to reduce the amount of cytokines and other inflammatory mediators. The congestion of the hospitals and their number of beds for blood transfusions are still limited and will not eliminate this dilemma with a blood purification. The effectiveness of the treatment must first be proven!
2. Cytodyn's Leronlimab already counteracts the overload of the number of beds in mild to moderate Covid-19 patients by 2 injections! In addition, the patients recover or do not get any severe symptoms.
3. Seriously ill Covid-19 patients can breathe freely after only 3 days and may even be able to leave the hospital if they are in good health!
4. The cost-benefit effect for 2 injections is more than justified, especially since a hospital day in the intensive care unit costs tens of thousands of dollars for the patients!
5. The repeated administration of the syringes should also speak for Leronlimab in view of the low side effects!
Last but least no Registration of Leronlimab at Clinicaltrials for Covid-19:
Registration: This final rule specifies requirements for registering applicable clinical trials at ClinicalTrials.gov. It requires that the responsible party register an applicable clinical trial not later than 21 calendar days after enrolling the first human subject (also referred to as participant or subject), and it specifies the data elements of clinical trial information that must be submitted at the time of registration. These data elements include the descriptive information, recruitment information, location and contact information, and administrative data elements listed in section 402(j) of the PHS Act, as well as additional required data elements under the Secretary's authority to modify the registration information requirements by Start Printed Page 64983rulemaking as long as such modifications improve, and do not reduce, the clinical trial information available to the public in ClinicalTrials.gov. We consider these additional required registration data elements necessary to enable the NIH to implement other statutory provisions, indicate the status of human subjects protection review of the trial, facilitate the public's ability to search and retrieve information from ClinicalTrials.gov, and help ensure that entries are meaningful and unambiguous. We note that some of these additional data elements required under this rule were included in ClinicalTrials.gov before FDAAA was enacted or have been implemented since 2007 as optional data elements (see Section IV.
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Link to FDA specification for Registration:
https://www.federalregister.gov/documents/201...submission
Anyone who has a little bit of brain and logic should understand the benefits of leronlimab and I hope the more patients treated with leronlimab, the more pressure on the authorities and politics will increase!
I also hope for the release of the Leronlimab Emergency Use Authorization in the next few days!
Just my immaterial opinion. Everyone can have their own.
2. Cytodyn's Leronlimab already counteracts the overload of the number of beds in mild to moderate Covid-19 patients by 2 injections! In addition, the patients recover or do not get any severe symptoms.
3. Seriously ill Covid-19 patients can breathe freely after only 3 days and may even be able to leave the hospital if they are in good health!
4. The cost-benefit effect for 2 injections is more than justified, especially since a hospital day in the intensive care unit costs tens of thousands of dollars for the patients!
5. The repeated administration of the syringes should also speak for Leronlimab in view of the low side effects!
Last but least no Registration of Leronlimab at Clinicaltrials for Covid-19:
Registration: This final rule specifies requirements for registering applicable clinical trials at ClinicalTrials.gov. It requires that the responsible party register an applicable clinical trial not later than 21 calendar days after enrolling the first human subject (also referred to as participant or subject), and it specifies the data elements of clinical trial information that must be submitted at the time of registration. These data elements include the descriptive information, recruitment information, location and contact information, and administrative data elements listed in section 402(j) of the PHS Act, as well as additional required data elements under the Secretary's authority to modify the registration information requirements by Start Printed Page 64983rulemaking as long as such modifications improve, and do not reduce, the clinical trial information available to the public in ClinicalTrials.gov. We consider these additional required registration data elements necessary to enable the NIH to implement other statutory provisions, indicate the status of human subjects protection review of the trial, facilitate the public's ability to search and retrieve information from ClinicalTrials.gov, and help ensure that entries are meaningful and unambiguous. We note that some of these additional data elements required under this rule were included in ClinicalTrials.gov before FDAAA was enacted or have been implemented since 2007 as optional data elements (see Section IV.
. Link to FDA specification for Registration:
https://www.federalregister.gov/documents/201...submission
Anyone who has a little bit of brain and logic should understand the benefits of leronlimab and I hope the more patients treated with leronlimab, the more pressure on the authorities and politics will increase!
I also hope for the release of the Leronlimab Emergency Use Authorization in the next few days!
Just my immaterial opinion. Everyone can have their own.
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