Ann: MSB Reports Q3 Financial Results and Operational Highlights, page-191

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LearningEachDay

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27/05/23

00:20

Post #: 67990852
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Originally posted by whytee: ↑

this is how things get misunderstood

This is what Learning Each Day posted

"Focus of back and forth with FDA right now is on labeling requirements."

This is what SI actually said:

Edward Tenthoff
Great. Thank you guys, and thanks for the detail on the presentation. So my friend Mike, was wondering what still has to be done for the ahead of the NDA? Are there any remaining pieces that need to be filed or any interactions with the FDA or at this point, are we really
just waiting for this to do today? Thanks.

Silviu Itescu
Well, having completed the manufacturing inspection which was the biggest item still outstanding, we continue to interact with FDA on a variety of questions that backwards and forwards in regard to the review. But other than that, really the major item that remains outstanding is a discussion around the specifics of the label. And that’s really – that still remains ahead of us and we’re very excited as we proceed towards the PDUFA date.

This means that infact there has not been ANY discussion with the FDA around "the specifics of the label". Infact I doubt there has been any discussion of the label at all. But somehow it got twisted into "the main focus of the back and forth with the FDA has been over the labelling". And other posters then took it further to suggest that approval must have already been given for them to be talking about "labelling.

Just sayin.

Expand

"This means that infact there has not been ANY discussion with the FDA around "the specifics of the label".

It could just as easily mean that the completion of those label discussions remains ahead, not that there hasn't been any discussion of the label at all.

Keep swinging, kiddo

MSB Price at posting: $1.08 Sentiment: Buy Disclosure: Held
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