Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-633

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ddwn

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27/05/24

18:24

Post #: 74031413
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Originally posted by JB1975: ↑

FDA says 001 trial shows product used in trial was effective.I said I was going to leave this alone for a while - no point repeating points already made etc if no one is listening but believe it or not this comment is actually intended to be for your benefit.

I understand (based on reading your posts) you to be a smart woman (person!) in more than one respect, so I know you know there is a difference between what the FDA says - that you or I or anyone can read or hear them saying first hand, and what someone else says they said.

I don't ever recall the FDA saying what you are saying they said. There were votes taken at ODAC and some statements might have got sort of towards what you are suggesting with some hefty caveats on them - I honestly don't recall and am not looking them up right now - but for your benefit I'll simply ask the rhetorical question what is your source for that assertion?

I don't actually want you to lose money, (I don't like seeing good things happen to essentially good people) but I absolutely respect your right to do what you think is best. You are sovereign of you.

I figure a question that you don't even have an expectation of answering can't possibly hurt you - and if you can give a source - that would be a very big thing - coming from the FDA themselves first hand I mean.

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@JB1975 "I understand (based on reading your posts) you to be a smart woman (person!) in more than one respect"... but, sometimes you need to step back from your analysis of the weed, you may see the trees, heck even the forest

Yeah, that's right - try to focus on the bigger picture every now and then!

Think about these two points:
If you were going to present your papers to an examiner (the FDA), would you try to be on your best behaviour or do something that would upset them e.g. mis-represent their feedback?
Also, with the ambulance chaser around - SI and Mesoblast are acutely aware of what they put out in the public via announcements. Would they state items that can be easily challenged as false and misleading?

I've left these items below from the previous two Mesoblast announcement for you to get back to inspecting the details!
MSB Price at posting: $1.16 Sentiment: Buy Disclosure: Held
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