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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-603

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pfeifer1982

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27/05/24

10:16

Post #: 74020787
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Originally posted by JB1975: ↑

Baz, you've responded to my post aimed @pfeifer1982, (the tag is to improve the chances you see the post not to urge you to reply in any sort of time-frame - take all the time you want) that's okay of course this is a forum, but I want to give pfeifer1982 every chance to reply first, if he wants to, and he can use any arguments you make that he agrees with, because that will be more time efficient for me and will involve less repetition. I will say, before going quiet to give pfeifer an opportunity to show if he wishes to respond that your opening presumption about N values is not wrong - too small a sample size is a problem - much of the problem - but its not all of the problem, (you make no reference to the inf gamma stuff I'd specifically included in my post and to which you are replying), I'll also offer for you and those ticking you to consider that your notion of a "fair go" is biased. It wouldn't be fair for any patients or parents of patients to pay for product that didn't work for instance. Also your argument that the FDA has changed - I grant some of the personnel have changed - no argument about that Steve Bauer won't be assessing your application for a biologics license if he is not there - buyt Matt Klinker will and I still hope and expect that whoever makes the decision on "has MSB provided at least one adequate and well controlled trial" will make that decision on the basis of sound science and sound statistical reasoning. Because its sound science and sound statistical reasoning (which should be objective not subjective) which produces the best results.

Learning relevant science and relevant stats - distinguishing between anecdote and real world evidence (if there is a difference - I grant that there may be one) is something that is in theory open to most of us.

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Haven't forgotten and I will reply but haven't had the time yet for anything more than a two liner, as I want to find the ASX announcements etc. again to reference them. Didn't think it was a matter of urgency to rush with a quick but incomplete reply as I have done on the other thread (long instead of lung and missing half the sentences etc.).

Last edited by pfeifer1982: 27/05/24

MSB Price at posting: $1.19 Sentiment: None Disclosure: Not Held
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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-603

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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-603

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