MSB 2.03% $1.45 mesoblast limited

Ann: Mesoblast Type A Meeting with FDA, page-283

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  1. 7,876 Posts.
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    So I answered the first question she asked. Where would they recruit from, I believe.

    Second question - why would anyone agree to participate? Many agree to participate in trials, this I how all other RCTs work. And the statement "... therefore it works..." in relation to it being used in the EAP: that doesn't follow. That doesn't mean it works. If it did, there wouldn't be a need for an RCT.

    That's.... that's not how anything works

    And the next question, how could the researchers consent people? Easily. They also know that it isn't clear whether it works. They would actually want to advance science, and they would likely know that an RCT would be more likely to lead to approval if it worked, and therefore help more people in the long run.

    As it is - not doing an RCT meant no approval, and far fewer people getting the product.

    I didn't specifically answer those questions because they have obvious answers. Wail all you want about the scientific method, but maybe don't invest in biotech companies if you don't understand these things.
 
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