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Post by bthomas55ep on Jun 25, 2024 18:58:20 GMT -5
Following ADA, I suppose the focus can shift back to the peds trial. I can't readily put my fingers on the projected timeline for the upcoming readout and study target completion date / filing date? Seems like it became a bit of a moving target. Anybody have a good feel for the expected events of the trial? Thx GLTA
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Post by cjm18 on Jun 25, 2024 19:02:09 GMT -5
Following ADA, I suppose the focus can shift back to the peds trial. I can't readily put my fingers on the projected timeline for the upcoming readout and study target completion date / filing date? Seems like it became a bit of a moving target. Anybody have a good feel for the expected events of the trial? Thx GLTA clinicaltrials.gov/study/NCT04974528September readout maybe.
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Post by bthomas55ep on Jun 25, 2024 19:54:08 GMT -5
Following ADA, I suppose the focus can shift back to the peds trial. I can't readily put my fingers on the projected timeline for the upcoming readout and study target completion date / filing date? Seems like it became a bit of a moving target. Anybody have a good feel for the expected events of the trial? Thx GLTA clinicaltrials.gov/study/NCT04974528September readout maybe. Thank you. I see the primary endpoint as 9/24. For some reason I was thinking there would be some kind of interim readout. Maybe that primary endpoint was it. Thanks again.
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Post by sayhey24 on Jun 26, 2024 9:19:28 GMT -5
Thank you. I see the primary endpoint as 9/24. For some reason I was thinking there would be some kind of interim readout. Maybe that primary endpoint was it. Thanks again. If I remember correctly the FDA pushed back on the trial and wanted another 6 months which puts it in the 3/25 timeframe. I think Mike said they were still working this with the FDA.
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Post by cjm18 on Jun 26, 2024 9:26:27 GMT -5
Thank you. I see the primary endpoint as 9/24. For some reason I was thinking there would be some kind of interim readout. Maybe that primary endpoint was it. Thanks again. If I remember correctly the FDA pushed back on the trial and wanted another 6 months which puts it in the 3/25 timeframe. I think Mike said they were still working this with the FDA. Slide 15 of May’s q2 call. Primary readout is 3q this year. investors.mannkindcorp.com/static-files/3d2fbb7e-34d6-4338-b499-c7d7098dad0f
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Post by prcgorman2 on Jun 26, 2024 9:35:10 GMT -5
Thank you. I see the primary endpoint as 9/24. For some reason I was thinking there would be some kind of interim readout. Maybe that primary endpoint was it. Thanks again. I'm with sayhey24 in that I recall comments about an interim readout being internal and used to determine whether a trial should continue. My problem is I don't remember if that was specific to the Peds trial (INHALE-1) or just a general practice in BP trials.
UPDATE: Oops, I misquoted what sayhey24 was saying which was with regard to an additional 6 months of trial. Sorry about that.
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Post by Clement on Jun 26, 2024 12:34:20 GMT -5
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Post by cjm18 on Jun 26, 2024 13:01:53 GMT -5
Thanks. So which is biggest driver of stock price? Date completion in q3 or data analysis in q4 Mnkd 201 readout is coming too.
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Post by prcgorman2 on Jun 26, 2024 13:38:45 GMT -5
Thanks. So which is biggest driver of stock price? Date completion in q3 or data analysis in q4 Mnkd 201 readout is coming too. Interesting question. I'm not sure how to estimate impact of trial readouts. I agree they can be substantial but estimating the effect (delta and sustainability) on stock price is way beyond me.
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Post by cjm18 on Jun 26, 2024 14:02:38 GMT -5
Thanks. So which is biggest driver of stock price? Date completion in q3 or data analysis in q4 Mnkd 201 readout is coming too. Interesting question. I'm not sure how to estimate impact of trial readouts. I agree they can be substantial but estimating the effect (delta and sustainability) on stock price is way beyond me. Mondays press release was an analysis or data readout?
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Post by prcgorman2 on Jun 26, 2024 14:18:44 GMT -5
Interesting question. I'm not sure how to estimate impact of trial readouts. I agree they can be substantial but estimating the effect (delta and sustainability) on stock price is way beyond me. Mondays press release was an analysis or data readout? Eh, neither an analysis, nor a data readout but I don't understand the question and so I'm unsure how to respond.
The bottom-line is I have no idea how an analyst goes about estimating impact (magnitude and duration) on share price from information in press releases or symposiums.
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