Third Quarter Earnings Call

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castlerockchris
Principal Investigator

Posts: 275

Third Quarter Earnings Call Nov 8, 2024 19:32:16 GMT -5 prcgorman2, tarheelblue004, and 2 more like this

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Post by castlerockchris on Nov 8, 2024 19:32:16 GMT -5

I agree with Clement on MC's "unfortunately" statement. I believe he was taking a page from Dr. M at UTHR in their positioning of the company as a public benefit company. As in, "Wouldn't it be nice to have more people working on this problem for the benefit of patients? Oh I guess it is just MNKD that sees the need to help these poor people live a better life." He then taps the microphone to make sure it is on so the FDA heard him.

Last Edit: Nov 8, 2024 19:33:27 GMT -5 by castlerockchris

parrerob
Postaholic

“I may not have gone where I intended to go, but I think I have ended up where I needed to be.” D.A.

Posts: 529

Sentiment: Long

Third Quarter Earnings Call Nov 21, 2024 10:13:26 GMT -5 sr71, cretin11, and 6 more like this

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Post by parrerob on Nov 21, 2024 10:13:26 GMT -5

This is MC speaking about PEDS....
"primary endpoint is at 6 months. And the data will be coming in here before the end of the year, so we'll be able to update shareholders. And we would expect a pre-NDA filing meeting in the first half. The real issue here is, do we want to try to argue that there should be a six-month filing versus a 12-month filing as the 12-month data will come out roughly late Q2 next year, and the filing would happen after."

I hope that the issue has already been analyzed and the path to follow already decided under a clear strategy to be taken with FDA.
Not sure but really hope.