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Post by sayhey24 on Oct 12, 2017 5:15:13 GMT -5
If the results were imminent and so positive, wouldn't it be prudent to wait to do the offering until after they announced the results?? Negotiations with a potential distributor are a lot harder when they know you need the money, asap. Mike has now increased his leverage in negotiating the deals and if he has gotten new players who are interested since the new label this gives him more time to open the discussions to more players. IMO, if he didn't think he had some real deals he would have sold a lot more than 10M shares at $6.
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Post by matt on Oct 12, 2017 7:50:49 GMT -5
There is not a lot of number crunching to do on a trial like this. There are only 60 participants and the study only lasted four weeks, so there is not a lot of time for data points to go missing (that is the number one headache in any clinical trial). This should be an easy study to data scrub, and the statistical analysis that is even possible on a two-arm study with only 60 subjects is very limited compared with a trial that enrolls thousands with detailed sub-group analysis. Without going into the intricacies of statistics, generally a study requires 30 subjects per arm to have minimally credible statistics, and this study barely reaches that threshold.
I believe the comment that they will have top line results later in Q4. However, note that this is an investigator sponsored study by the University of Colorado so it is not Mannkind's call when the data gets published. The sponsor gets to make that decision, and they may want to announce it at a conference or in a medical journal. Academics have different priorities than commercial companies, but free data and more publication is never a bad thing..
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Post by od on Oct 12, 2017 8:31:58 GMT -5
In May, MNKD stock ran up to $1.90+ after announcement of the STAT study to be started mid June. There was a one day delay before folks figured it out. (Sunday to Tuesday) The STAT study is a 99% positive conclusion for Mannkind as I mentioned in a previous thread. My opinion of course but based on 40 years as a Type 1 and 29 months as an Afrezza user! ! ! The 10 million shares sold at $6 is no coincidence as the STAT study is coming to a conclusion. The facts/results of the STAT study were conclusive weeks ago (again, imho). Do you think those 10 million Shares would have been sold at $6 after a 300% run up in such a short time without the STAT evidence presented? No chance. When the STAT study data is presented, it's off to the races again for MNKD share price and the Adam Fs of the world can watch and weep. No brainer. Are you saying that ongoing results of an academic investigator sponsored trial were shared, out of protocol, with the investors who purchased the 10 million shares at $6.00?
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Post by sellhighdrinklow on Oct 24, 2017 21:05:45 GMT -5
I'm hoping the volatility in stock price is a result of pending news of the results of the study.
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Post by straightly on Oct 24, 2017 21:30:04 GMT -5
I'm hoping the volatility in stock price is a result of pending news of the results of the study. Remember reading on this board the numbers will be out begining next year but that was just a guess. Any info anywhere on the schedule?
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Post by dreamboatcruise on Oct 25, 2017 0:20:12 GMT -5
I'm hoping the volatility in stock price is a result of pending news of the results of the study. Remember reading on this board the numbers will be out begining next year but that was just a guess. Any info anywhere on the schedule? Management has stated results in 2018, but it is not under their control since it is university sponsored. So when in 2018 would have to do with how it is released... e.g. journal vs ADA conference.
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Post by sportsrancho on Oct 25, 2017 5:53:01 GMT -5
In May, MNKD stock ran up to $1.90+ after announcement of the STAT study to be started mid June. There was a one day delay before folks figured it out. (Sunday to Tuesday) The STAT study is a 99% positive conclusion for Mannkind as I mentioned in a previous thread. My opinion of course but based on 40 years as a Type 1 and 29 months as an Afrezza user! ! ! The 10 million shares sold at $6 is no coincidence as the STAT study is coming to a conclusion. The facts/results of the STAT study were conclusive weeks ago (again, imho). Do you think those 10 million Shares would have been sold at $6 after a 300% run up in such a short time without the STAT evidence presented? No chance. When the STAT study data is presented, it's off to the races again for MNKD share price and the Adam Fs of the world can watch and weep. No brainer. Are you saying that ongoing results of an academic investigator sponsored trial were shared, out of protocol, with the investors who purchased the 10 million shares at $6.00? Maybe Dexcom bought in since they were part of the study.
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Post by wmdhunt on Oct 25, 2017 8:35:17 GMT -5
Time for more MNKD imo.
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Post by peppy on Oct 25, 2017 9:52:14 GMT -5
Official Title: 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
clinicaltrials.gov/ct2/show/NCT03143816?term=STAT&cond=Diabetes&draw=1&rank=1
If the primary/secondary endpoint results show superiority against using insulin aspart (Novolog) alone for significantly reducing/controlling post-prandial glucose excursions (PPGE) and reduction of HbA1c, wouldn't you much rather see the results published in Lancet than at the ADA Scientific Meetings? Publishing in a major medical journal would educate far more doctors about the merits of Afrezza than an ADA presentation would, IMO.
There may be further label ramifications from this University of Colorado study as well...
This study is currently recruiting participants.
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Post by kc on Oct 25, 2017 10:30:32 GMT -5
60 enrolled and a 15 day study is not a long period of time or a very big group.
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Post by mango on Oct 25, 2017 10:45:16 GMT -5
60 enrolled and a 15 day study is not a long period of time or a very big group. It's a Phase 4 trial, it doesn't require that. With the Deacon G5 all the participants randomized into the Afrezza arm will be put on a CGM. This is basically mimicking what VDex has been doing and taking about. Anyways, they can each get 288 readings in 24 hours. That's 8,064 readings per person. Anything beyond a month is ludicrous, IMO.
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Post by itellthefuture777 on Oct 25, 2017 11:07:22 GMT -5
Are we to assume that the results of this study will not be disclosed until the next American Diabetes Association annual meeting, scheduled for Orlando Florida, June 22-28. 2018? I really hope this is not the case. The only thing holding up sales is they just got training the last 2 weeks...for the new label...the finance was for output of reports..and advertisement..so a primetime commercial not on a pay to watch channel..would be great! With only 2% of U.S. diabetics knowing about Afrezza..thats 98% potential when they do hear about it...The stock is severely over sold..for a superior label...largest market insulin..fastest in&out and only inhaled monomeric in the world...Should do an In&Out Commercial!
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Post by mnholdem on Oct 25, 2017 11:33:44 GMT -5
There is not a lot of number crunching to do on a trial like this. There are only 60 participants and the study only lasted four weeks, so there is not a lot of time for data points to go missing (that is the number one headache in any clinical trial). This should be an easy study to data scrub, and the statistical analysis that is even possible on a two-arm study with only 60 subjects is very limited compared with a trial that enrolls thousands with detailed sub-group analysis. Without going into the intricacies of statistics, generally a study requires 30 subjects per arm to have minimally credible statistics, and this study barely reaches that threshold. I believe the comment that they will have top line results later in Q4. However, note that this is an investigator sponsored study by the University of Colorado so it is not Mannkind's call when the data gets published. The sponsor gets to make that decision, and they may want to announce it at a conference or in a medical journal. Academics have different priorities than commercial companies, but free data and more publication is never a bad thing.. Also to be considered is that academic studies must typically be peer-reviewed if they are to have any credibility. This adds to the timeline, as does the physical preparation of the report itself. I'm rooting for this study to be published in a major medical journal (e.g. Lancet). I think that most HCPs that deal with diabetes focus only on a1C results, so publishing new data on the significance of an insulin's speed in controlling diabetes will educate and eventually convince many physicians that Afrezza may be a good choice for their patients who struggle with the disease.
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Post by ghochr on Oct 25, 2017 11:55:43 GMT -5
Are you saying that ongoing results of an academic investigator sponsored trial were shared, out of protocol, with the investors who purchased the 10 million shares at $6.00? Maybe Dexcom bought in since they were part of the study. University of Colorado? 😜 because they sponsored the study
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Post by xanet on Oct 25, 2017 14:15:28 GMT -5
There is not a lot of number crunching to do on a trial like this. There are only 60 participants and the study only lasted four weeks, so there is not a lot of time for data points to go missing (that is the number one headache in any clinical trial). This should be an easy study to data scrub, and the statistical analysis that is even possible on a two-arm study with only 60 subjects is very limited compared with a trial that enrolls thousands with detailed sub-group analysis. Without going into the intricacies of statistics, generally a study requires 30 subjects per arm to have minimally credible statistics, and this study barely reaches that threshold. I believe the comment that they will have top line results later in Q4. However, note that this is an investigator sponsored study by the University of Colorado so it is not Mannkind's call when the data gets published. The sponsor gets to make that decision, and they may want to announce it at a conference or in a medical journal. Academics have different priorities than commercial companies, but free data and more publication is never a bad thing.. Also to be considered is that academic studies must typically be peer-reviewed if they are to have any credibility. This adds to the timeline, as does the physical preparation of the report itself. I'm rooting for this study to be published in a major medical journal (e.g. Lancet). I think that most HCPs that deal with diabetes focus only on a1C results, so publishing new data on the significance of an insulin's speed in controlling diabetes will educate and eventually convince many physicians that Afrezza may be a good choice for their patients who struggle with the disease.
In my field (plant sciences) it is pretty common to present preliminary results at a conference, which does not require peer-review, and to follow up with a peer-reviewed publication several months (or even years) later.
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