MSB 1.62% $1.83 mesoblast limited

You have never denied that MSB must go through the FDA process,...

  1. 149 Posts.
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    You have never denied that MSB must go through the FDA process, and I have never suggested that you suggested it. So, your usual scattering of chaff to deflect incoming. However, you have repeated implied, including in your most recent message, that it will somehow be easier for MSB to navigate the regulatory process. I do not believe that will be the case.

    To address your points specifically:
    "The scale and costs of FDA DRUG trials reflect a vastly higher range of risks than MSB faces":
    Not true. The FDA do not differentiate, at least in the demonstration of safety and efficacy, between drugs and biologicals. Arguably, approval of biologicals is more complex because of the complex nature of manufacturing, as compared to small molecule therapeutics.

    "Overwhelming efficacy will enable fast tracking of the heart therapy to market:
    That is a possibility. If - and I believe that it is a very large IF - "overwhelming efficacy" is achieved. Nowhere have I read what "overwhelming efficacy" actually means in this context, but knowing what I know about therapeutics development, I believe it to be a challenging hurdle. Most therapeutics - even the most fantastically expensive oncology medications - offer marginal improvements over previously available products.
    You will say, yes, but these are STEM CELLS!!! Revolutionary!!! With bacon!!!
    I say that they have to prove themselves, and to assume that the achievement of "overwhelming efficacy" is a strong likelihood is misguided.

    "Diagnostic methods...blah, blah, blah, targeting etc":
    In the announcement, the company claimed that the catheter would accelerate recruitment in the study. They made no claims in respect to it increasing efficacy; if that were the case, I feel certain that MSB would have mentioned it. They are not reticent in respect to the communication of good tidings.
    So, you might have made that up.

    I did slam the door shut, but actually, I'm starting to enjoy this again. I've got a bit more time on my hands of late, and a man's got to have a hobby.
 
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