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Post by ktim on Jan 31, 2020 17:09:28 GMT -5
When there’s kids at school using Afrezza and other kids see it and think it’s cool. That’s when it changes. Parents will research on their own and find a doctor who prescribes. Absolutely !! and game on. Just need the pediatric results and FDA green light. That has to be right around the corner - at least I sure hope it is. I can only speculate about results of peds approval, same as anyone, but at least the issue of timing is something we do have real facts. They still have another trial to do. In the last public event I know of (Piper Jaffray conference) Mike gave update on peds saying that they were in discussion with FDA on trial design. Without going back and reviewing it, my recollection is that he said they were hopeful it would be reduced from 52 weeks to 26 weeks, but clearly indicating that wasn't a settled issue. Once they settle on protocol they need to recruit. After it is finished MNKD crunches the data for some number of months and FDA then takes some number of months to review. Bare minimum would seem 18 months, or 24 if they don't get approval for shortened trial. Is that what you meant by right around the corner? Or otherwise what is your reasoning for the saying that it "has to be right around the corner"... perhaps you meant MNKD really needs a catalyst and you view this is the most likely one. |
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Post by rfogel on Jan 31, 2020 19:03:07 GMT -5
Regarding the pediatric trial, the CEO said in a CC that they expected info from the FDA about the protocol before the end of last year. Did the FDA come through with anything?
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Post by mnholdem on Feb 1, 2020 9:39:58 GMT -5
The FDA announced years ago that it would begin accepting real-world data in its ongoing evaluations of drugs. Since launch there have been over 118,000 prescriptions written for Afrezza. mnkd.proboards.com/thread/1742/afrezza-script-counts-symphony-dataCoupled with MannKind CMO David Kendall's post-hoc lung safety data study presentation and the FDA, a cause can (and perhaps should) be made that the time has come to determine whether the requisite post market 5-year lung safety study is even necessary. Sufficient data may be available to amend the label or to require a shorter study at this point by accepting real world data, evaluation of total reported lung issues (major adverse event) and post-hoc data. The is an important issue and the removal of the black box warning could be a pivotal event leading to significant changes in adoption of Afrezza by healthcare professionals, academics, patients and families of patients. If if elected by shareholders to a director seat, I would have very focused questions about progress to date and assertive forward planning.  |
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Post by agedhippie on Feb 1, 2020 11:26:13 GMT -5
The FDA announced years ago that it would begin accepting real-world data in its ongoing evaluations of drugs. Since launch there have been over 118,000 prescriptions written for Afrezza. mnkd.proboards.com/thread/1742/afrezza-script-counts-symphony-dataCoupled with MannKind CMO David Kendall's post-hoc lung safety data study presentation and the FDA, a cause can (and perhaps should) be made that the time has come to determine whether the requisite post market 5-year lung safety study is even necessary. Sufficient data may be available to amend the label or to require a shorter study at this point by accepting real world data, evaluation of total reported lung issues (major adverse event) and post-hoc data. ... I suspect that sales have not reached the level where there is sufficient volume to satisfy the FDA. The design called for 8,000 high risk patients over five years and the current population doesn't get anywhere near matching that. I suspect at best we have around 9,000 people using Afrezza today based on the Symphony numbers. |
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Post by ktim on Feb 2, 2020 15:04:42 GMT -5
The FDA announced years ago that it would begin accepting real-world data in its ongoing evaluations of drugs. Since launch there have been over 118,000 prescriptions written for Afrezza. mnkd.proboards.com/thread/1742/afrezza-script-counts-symphony-dataCoupled with MannKind CMO David Kendall's post-hoc lung safety data study presentation and the FDA, a cause can (and perhaps should) be made that the time has come to determine whether the requisite post market 5-year lung safety study is even necessary. Sufficient data may be available to amend the label or to require a shorter study at this point by accepting real world data, evaluation of total reported lung issues (major adverse event) and post-hoc data. The is an important issue and the removal of the black box warning could be a pivotal event leading to significant changes in adoption of Afrezza by healthcare professionals, academics, patients and families of patients. If if elected by shareholders to a director seat, I would have very focused questions about progress to date and assertive forward planning. Interesting question whether lack of reported adverse events would ever be enough to convince FDA to drop requirement for a post marketing safety study. Though quite speculative until there is at least one example of it happening. Does MNKD have that type of luck to be the first company to get such treatment  Though I don't know how you'd link that with black box warning. I've copied the black box warning below. Almost by definition the current patient base wouldn't give evidence to negate these since the people with these conditions should have been excluded from that Afrezza patient base. WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE • Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA [see Warnings and Precautions (5.1)]. • AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD [see Contraindications (4)]. • Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients [see Dosage and Administration (2.5), Warnings and Precautions (5.1)]. |
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Post by xanet on Feb 4, 2020 11:52:18 GMT -5
Tom’s son Jake shows his Dreamboat off to everyone because they all eat together. He’s in college now in Arizona. I know the family is friends with several other families that have T1 kids. People have gotten a hold of Tom from other states just because I’ve talked about it on Twitter. You have to take Afrezza when you eat. So for grade school for instance, it’s not like the kid is sent to the nurse 20 minutes before lunch and then goes into the hall and no one knows. In our school district, medications (even lip balm in grade school...  ) are kept locked up and administered by the school nurse. Any student requiring insulin stops at the office enroute to lunch. It's a bad system for a PWD. |
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) are kept locked up and administered by the school nurse. Any student requiring insulin stops at the office enroute to lunch. It's a bad system for a PWD.