I am furious RemL has not been approved and this helps explain why. It has proven to be safe and effective, yet the FDA has not approved it yet. According to these comments it suggests that big pharma's influence is affecting it and they have been able to delay effective drugs by up to 20 years. I for one do not want to wait 20 years. It might be approved soon under a EUA, but can we wait that long and how many lives will be lost. We should be doing staged additional RCT to publicize the results of RemL and force the public to take notice and put pressure on the FDA. eg. do 20 targeted RCT Ards patients, publish the results. Do a further 20 RCT Ards patients, publish the results. Gradually build up a dossier on the number of people saved. This will bring pressure on the FDA to eventually do the right thing. Demonstrate it saves peoples lives. Otherwise we could be waiting another 20 years for the FDA to approve RemL. There seems to be inaction. There are things happening behind the scene, but it is too slow and could just be a delay tactic by the FDA because we are not big pharma.
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