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Post by sportsrancho on Oct 11, 2017 13:58:35 GMT -5
STAT Oct 15th
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Post by captainwalker on Oct 11, 2017 14:06:04 GMT -5
Noob alert - sincere apologies - what does that mean Sports?
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Post by peppy on Oct 11, 2017 14:07:40 GMT -5
STAT trial results due OCT 15th? oh, ha ha. Love you.
clinicaltrials.gov/ct2/show/NCT03143816
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT) Estimated Enrollment: 60 Anticipated Study Start Date: September 30, 2017 Estimated Study Completion Date: October 15, 2017 Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure)
Primary Outcome Measures: •Improved time in range (70-180 mg/dl) with TI on CGM [ Time Frame: 4 weeks ] •Better post-prandial glucose excursion (1-4 hours after meals) with TI [ Time Frame: 4 weeks ]
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Post by cjc04 on Oct 11, 2017 14:13:22 GMT -5
STAT trial results due OCT 15th? oh, ha ha. Love you.
clinicaltrials.gov/ct2/show/NCT03143816
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT) Estimated Enrollment: 60 Anticipated Study Start Date: September 30, 2017 Estimated Study Completion Date: October 15, 2017 Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure)
study completion date is 10/15, anyone have any idea when we'll hear about results?
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Post by sportsrancho on Oct 11, 2017 14:15:33 GMT -5
Very soon, IMO:-)
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Post by peppy on Oct 11, 2017 14:17:14 GMT -5
right after this placement closes and prior to next weeks option expiration? no clue. you know afrezza is going to nail it with a cgm.
Primary Outcome Measures:
•Improved time in range (70-180 mg/dl) with TI on CGM [ Time Frame: 4 weeks ] •Better post-prandial glucose excursion (1-4 hours after meals) with TI [ Time Frame: 4 weeks ]
table 4 www.screencast.com/t/AgBRLBTyoP
*Attention, there are not 4 weeks between the start date and completion date.* drat. Anticipated Study Start Date: September 30, 2017 Estimated Study Completion Date: October 15, 2017 Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure)
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Post by mytakeonit on Oct 11, 2017 14:32:23 GMT -5
What's wrong peppy? They used Afrezza and were cured in 2 weeks. It's normal ...
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Post by mnholdem on Oct 11, 2017 14:45:13 GMT -5
Agreed. It was a 4-week study.
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Post by dreamboatcruise on Oct 11, 2017 14:49:32 GMT -5
Agreed. It was a 4-week study. Though a thread that was just locked asked about whether they might hold the release to be presented at ADA. I think that is valid question, given that ADA doesn't allow already released study data to be presented (I believe). I hope they don't do this. They could still present the data to potential international partners, but I think it should be released as soon as possible.
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Post by madog365 on Oct 11, 2017 16:16:05 GMT -5
The short thesis to date has been bankruptcy, and today that was taken off the table for at least another year. Not to mention at an offering price that would have been a 52 week high for the company as far back as yesterday. MannKind now has over 80 million in cash to execute their vision for Afrezza. Short term the Deerfield debt will likely be converted into shares again, they are currently sitting with massive returns on their 5m shares from June and will be looking to repeat that process. Locust Walk is likely nearing a deal with a development partner for trep-t Mnkd is likely nearing another small milestone payment with receptor Afrezza in Brazil is likely nearing acceptance as that process takes about 8 months Other international partnerships which were expected in the near term back in May , could be announced any day
So maybe not today, but very soon, I believe many of The large short sellers will begin their exit. Call option volume has been high, and they are loaded up to hedge for the squeeze potential. -M When you have an expectation that something will happen any day for a period of five months, I think that means what you are calling an expectation is really a wish. Most of what you are now predicting is likewise not grounded in anything that we really know with regard to the nearness of the events. For instance, we know what Locust Walk was retained for, but we really have no idea whether they are nearing a deal... no facts that we have would indicate the level of likeliness for a trep-t deal. One that we actually do know a timeline on is the time in range STAT trial which should be out years end. I would call it speculation, which is something all of us do on this board daily. Anything other than speculation would be considered insider knowledge. You are right i have no idea about the nearness of a trep-t deal but i do believe we are close. One clue is the description Mannkind has started to use about their company as of 9/5 within their press releases. Prior to 9/5 Mannkind described itself "MannKind Corporation focuses on the discovery and development of therapeutic products for patients with diseases such as diabetes" As of 9/5 press releases have added pulmonary arterial hypertension "MannKind Corporation focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension" It was clear Epi took a backseat and i like to believe that direction came from Locust Walk which determined a better opportunity with Trep-T As far as international deals, it continues to show up in Mike's presentations. Mike has delivered on every one of his promises so far and he was clear that a second deal likely in the middle east is coming. -- Also the one thing that you mentioned knowing the timing on the STAT trial is incorrect. Mike mentioned results likely be out next year, not this year.
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Post by dreamboatcruise on Oct 11, 2017 16:41:05 GMT -5
When you have an expectation that something will happen any day for a period of five months, I think that means what you are calling an expectation is really a wish. Most of what you are now predicting is likewise not grounded in anything that we really know with regard to the nearness of the events. For instance, we know what Locust Walk was retained for, but we really have no idea whether they are nearing a deal... no facts that we have would indicate the level of likeliness for a trep-t deal. One that we actually do know a timeline on is the time in range STAT trial which should be out years end. I would call it speculation, which is something all of us do on this board daily. Anything other than speculation would be considered insider knowledge. You are right i have no idea about the nearness of a trep-t deal but i do believe we are close. One clue is the description Mannkind has started to use about their company as of 9/5 within their press releases. Prior to 9/5 Mannkind described itself "MannKind Corporation focuses on the discovery and development of therapeutic products for patients with diseases such as diabetes" As of 9/5 press releases have added pulmonary arterial hypertension "MannKind Corporation focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension" It was clear Epi took a backseat and i like to believe that direction came from Locust Walk which determined a better opportunity with Trep-T As far as international deals, it continues to show up in Mike's presentations. Mike has delivered on every one of his promises so far and he was clear that a second deal likely in the middle east is coming. -- Also the one thing that you mentioned knowing the timing on the STAT trial is incorrect. Mike mentioned results likely be out next year, not this year. We know that MNKD plans to file IND for for it, so I don't think that change in language about what MNKD does would be an indicator of a "deal", but rather an indicator that it is an actively pursued pipeline API. I was going by the bar that was on slide 13 for STAT trial. After someone raised the issue of ADA presentation, I do worry whether there could be a large gap in time between MNKD having the results and releasing/presenting/publishing them. So, I'll retract any assumption about what that bar on slide 13 might mean with regard to release of the results, as that might have only been intended to indicate the duration of the trial. I would think worst case they may hold it for ADA... I hope they don't.
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