The progression of CRP, SAA etc show the patients that are desperately in need of Rem-L but unfortunately right now can't get it. It must be very difficult to be a medical professional in that situation.
@MJC73 I would hope that in the USA anyway that people would be able to access Remestemcel-L through couple of avenues so I am not sure I agree with that comment ....
1. Children suffering MIS-C can access it through the ongoing EAP if their medical professionals requested it as there is no clinical hold on Remestemcel-L or it wouldn't be listed as "available" for EAP on the clinical trials website....
https://clinicaltrials.gov/ct2/show/NCT04456439?term=Remestemcel-L&cond=MIS-C Associated with COVID-19&draw=2&rank=1
Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
View attachment 3577832
2. Right to Try provisions would surely enable some patients to access Remestemcel-L in certain circumstances for COVID-19 ARDS .... whether it arrived in time for effective treatment could be an issue though I guess
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
Right to Try
The Right to Try Act, or the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, was signed into law May 30, 2018.
This law is another way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain unapproved treatments.
An eligible patient is a patient who has:
- Been diagnosed with a life-threatening disease or condition
- Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)
- And has provided, or their legally authorized representative has provided, written informed consent regarding the eligible investigational drug to the treating physician
An eligible investigational drug is an investigational drug:
- For which a Phase 1 clinical trial has been completed
- That has not been approved or licensed by the FDA for any use
- For which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA
- Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDA
... and yes
@Pledge you are 100% correct - I meant COVID-19 ARDS, which is what our phase 3 trial was for .... slackness on my part for not typing it in full - probably need more coffee at the time
(20min delay)