MSB 1.73% $1.18 mesoblast limited

FDA approved without Randomized Controlled Trial

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    The FDA just approved two malaria drugs Hydroxychloroquine and its (more side effect prone cousin) Chloroquine for the treatment of COVID-19:
    https://www.biopharmadive.com/news/coronavirus-fda-chloroquine-emergency-use/575097/

    So here are my observations:
    1. No randomized clinical trial has proven the drugs to be effective, but observational studies in France and China have raised hopes of some benefit
    2. This approval was based on FDA's Emergency Use Authorization (EUA)
    3. lt limits use of these two drugs to only those patients who can't participate in a clinical trial or are ineligible - this means patients who would be using Mesoblast's stem cell therapy (in a clinical trial) would not be using these two drugs
    4. This is a very unusual approval by the FDA especially given the absence of randomized study evidence supporting the drug's use against COVID-19 - I attribute the approval to two things:
    a) Trump
    b) Desperation (which is valid)

    So what does this have to do with Mesoblast?
    Here's my thinking:
    a) Mesoblast can still do a clinical trial on those patients who are not taking the above medication(s). I believe FDA limited the use of these two drugs to only those patients who can't participate in a clinical trial or are ineligible so that the efficacy of a stem cell treatment (or any other treatment) cannot conflict with mode of action of these two approved medications
    b) Even if both these drugs work on COVID-19 patients, I strongly believe they will not work on treating ARDS to save lives. Plus they have unwanted side effects.
    c) Mesoblast went from stating that a trial would commence "in a few weeks" to "imminently". That tells me that we (and the government agencies) are eager to get a randomized controlled trial started quickly and finish it quickly.
    d) No word from Athersys as to when they will be starting a test. Mesoblast also stated they will be using 48 patients in their trial, Athersys has NOT provided any detail.
    e) As others and I stated previously, Mesoblast has a PROVEN advantage of manufacturing MSCs on a mass commercial scale. Athersys - not.




 
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