|
Post by sportsrancho on Oct 25, 2017 18:41:31 GMT -5
|
|
|
Post by sellhighdrinklow on Oct 25, 2017 19:39:13 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? Yes
|
|
Tinkerbell
Researcher
Watcher of the Skies
Posts: 143
|
Post by Tinkerbell on Oct 26, 2017 7:22:38 GMT -5
Mike is waiting on the data to present to payors in January. More than one payor has asked for additional data to support the claims regarding Afrezza's superior action when it comes to time in range and subsequent HbA1c lowering seen in just 4 weeks. That's the reason for the STAT study and as Afrezza is already approved, this will answer several questions for payors.
Regarding publication, the results of this study will likely be released in early 2018 perhaps at an international meeting overseas. I suspect it will be timed very specifically for this reason. And, as more than one country will be reviewing the dossier for approval, adding this study's results as an addendum to it is required anyway. It will also be submitted to the FDA.
As as far as the ADA meeting in summer 2018, in my view, a preliminary showcase of the peads trial early results should be presented. By then, there will be sufficient data to share regarding early trends in this population and remember, Dr. Garag is Professor of Pediatrics and an investigator on this trial. He is the rising KOL who'll present his results at meetings etc.
The above seems a more reasonable strategy but I'm not an insider to Mike's thinking. This is my opinion only.
|
|
|
Post by mnholdem on Oct 26, 2017 8:08:07 GMT -5
Tinkerbell - I was beginning to think that you had joined spiro in Siberia. I really appreciate the way you logically think things through and your level of expertise is fitting and welcome on ProBoards. Excellent analysis of what may happen with the STAT results.
|
|
|
Post by tw12 on Oct 26, 2017 8:24:40 GMT -5
Tink' (rhymes with think): I too am glad to see your well-reasoned, well-experienced voice back on ProBoards!
|
|
Tinkerbell
Researcher
Watcher of the Skies
Posts: 143
|
Post by Tinkerbell on Oct 26, 2017 9:12:50 GMT -5
Tinkerbell - I was beginning to think that you had joined spiro in Siberia. I really appreciate the way you logically think things through and your level of expertise is fitting and welcome on ProBoards. Excellent analysis of what may happen with the STAT results. Thanks for the compliment. I didn't leave but just so busy with life in general though I have been busy defending MNKD on several other boards. Still here and enjoying what I see happening at MannKind. All good!
|
|
|
Post by digger on Oct 26, 2017 9:32:53 GMT -5
According to the clinicaltrials website the study is still recruiting. It says it didn't begin until September 30 and is enrolling 60 people. It also says "there will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits)." I would think it would take many months to complete.
|
|
|
Post by mnholdem on Oct 26, 2017 9:42:15 GMT -5
4 visits and 3 phone calls over a 30-day period? Hell, that's a typical morning for Sports. The study is only for 60 patients.
|
|
Tinkerbell
Researcher
Watcher of the Skies
Posts: 143
|
Post by Tinkerbell on Oct 26, 2017 12:24:26 GMT -5
According to the clinicaltrials website the study is still recruiting. It says it didn't begin until September 30 and is enrolling 60 people. It also says "there will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits)." I would think it would take many months to complete. If you look at the slides presented by Ray Urbanski at Q2 call, you will see that STAT finishes in early January. So at a minimum, all patients need to be enrolled and through 4 weeks of treatment no later than mid-late December. 30 subjects will continue on their therapy as is (and some may already be on a CGM; if not, they will need to learn to use one). 30 subjects will learn about Afrezza and ditto on the CGM per above. If the center started patient enrollment in September, they need to enroll ~ 20 subjects or more per month to complete enrollment by mid December. A tall order unless they already prescreened a ton of subjects and lined them up to participate during the month of September with consent signing planned for October. The only way to really find out is to contact the center itself to inquire if they are still accepting study subjects. Personally, I draw the line there. It's a waste of precious time for the study coordinator and in my view, unethical. The company should be able to report on subject enrollment progress when they report in November. In fact, sending an email to investor relations in advance or to Mike to provide an update would be better in my view.
|
|
|
Post by therealisaching on Oct 26, 2017 12:51:55 GMT -5
According to the clinicaltrials website the study is still recruiting. It says it didn't begin until September 30 and is enrolling 60 people. It also says "there will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits)." I would think it would take many months to complete. If you look at the slides presented by Ray Urbanski at Q2 call, you will see that STAT finishes in early January. So at a minimum, all patients need to be enrolled and through 4 weeks of treatment no later than mid-late December. 30 subjects will continue on their therapy as is (and some may already be on a CGM; if not, they will need to learn to use one). 30 subjects will learn about Afrezza and ditto on the CGM per above. If the center started patient enrollment in September, they need to enroll ~ 20 subjects or more per month to complete enrollment by mid December. A tall order unless they already prescreened a ton of subjects and lined them up to participate during the month of September with consent signing planned for October. The only way to really find out is to contact the center itself to inquire if they are still accepting study subjects. Personally, I draw the line there. It's a waste of precious time for the study coordinator and in my view, unethical. The company should be able to report on subject enrollment progress when they report in November. In fact, sending an email to investor relations in advance or to Mike to provide an update would be better in my view. Mike C at last months Cantor Fitzgerald presentation:
Our STAT trial, which is really looking at Afrezza plus Dexcom will be – we’ll get those results in late fall and they’ll be presented next year
|
|
|
Post by od on Oct 26, 2017 16:16:34 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? Yes It did not happen.
|
|
|
Post by peppy on Oct 26, 2017 16:32:13 GMT -5
According to the clinicaltrials website the study is still recruiting. It says it didn't begin until September 30 and is enrolling 60 people. It also says "there will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits)." I would think it would take many months to complete. If you look at the slides presented by Ray Urbanski at Q2 call, you will see that STAT finishes in early January. So at a minimum, all patients need to be enrolled and through 4 weeks of treatment no later than mid-late December. 30 subjects will continue on their therapy as is (and some may already be on a CGM; if not, they will need to learn to use one). 30 subjects will learn about Afrezza and ditto on the CGM per above. If the center started patient enrollment in September, they need to enroll ~ 20 subjects or more per month to complete enrollment by mid December. A tall order unless they already prescreened a ton of subjects and lined them up to participate during the month of September with consent signing planned for October. The only way to really find out is to contact the center itself to inquire if they are still accepting study subjects. Personally, I draw the line there. It's a waste of precious time for the study coordinator and in my view, unethical. The company should be able to report on subject enrollment progress when they report in November. In fact, sending an email to investor relations in advance or to Mike to provide an update would be better in my view. www.screencast.com/t/TlH12suxDge
|
|
|
Post by brewguy on Oct 26, 2017 17:04:24 GMT -5
IMO this is a very flawed study. Allowing the afrezza arm to administer insulin as much as they need to post meals doesn't make sense. Of course you will see better "time in range" when that group is allowed to continually admin insulin. The injectable group only does it once prior to their meal so why not same restriction with afrezza group?
|
|
|
Post by peppy on Oct 26, 2017 17:11:18 GMT -5
IMO this is a very flawed study. Allowing the afrezza arm to administer insulin as much as they need to post meals doesn't make sense. Of course you will see better "time in range" when that group is allowed to continually admin insulin. The injectable group only does it once prior to their meal so why not same restriction with afrezza group? There is a reason for that. Afrezza is an insulin you can take. with out it killing you. afrezza allows for better after meal blood glucose control.
If the study allowed the subq rapid acting analog post meal insulin to control post meal spike, they would die. Subq RAA the diabetic, goes high, then low.
|
|
|
Post by liane on Oct 26, 2017 17:25:08 GMT -5
|
|