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Post by agedhippie on Apr 18, 2016 17:20:02 GMT -5
Regarding mistakes along the way, both the FDA and SNY had final say with respect to trial design and marketing, respectively. It's the same argument. MNKD had limited options to deal with FDA trial design and SNY marketing. For this reason, I do not expect a superiority trial EVER, and I was happy to be rid of SNY. Now, I can short them [SNY] with impunity and not feel bad about it -- just unsure how to take a position against the FDA.  BTW, superiority is not needed to WIN. It would be extremely difficult to prove under the current FDA, and it would be a further waste of resources. The long-term safety study should provide ample empirical evidence to garner support for Al Mann's hypothesis. Until that time, compete with the non-inferior RAA's. lakon, can you explain why you think a superiority trial won't be done? My impression is that the trial design required for approval was complicated by Afrezza being a new drug and thereby posing a risk to patients if used in a non-standard way. Tinfoil hat conspiracies aside, I'd like to think we've moved on from there and the next trial can be designed to highlight Afrezza's advantages. It would be easy to do a superiority trial, the problem would be the time and the cost. The PK/PD studies support the new dosing regime and the trial protocol just needs to then be designed to incorporate that. |
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Post by tayl5 on Apr 19, 2016 0:17:03 GMT -5
I see a superiority trial as fundamental to forward progress and fervently hope the company does as well. If we have formal trial results that replicate what users have experienced anecdotally, the doctors pay attention, the discussions with payors are much easier, and the shorts have to focus their attention elsewhere.
Cost and time-wise, this isn't an Alzheimer's trial. Let's bite the bullet and get it done. From a marketing perspective, even the exposure of the doctors operating the trial sites to Afrezza is valuable and will win us prescribers if the trial is succcessful.
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Post by peppy on Apr 19, 2016 6:30:47 GMT -5
Spiro believes that at this point, MNKD is focused solely on developing a business model that will jump start the second launch of Afrrezza. Let's face reality, a successful launch and strategy will propel the share price. An unsuccessful launch will result in eventual doom. Spiro here, betting on the M & M boys ( Matt and Mike ) getting the job done. sure looks like the ground work is being completed. what we have going for us now is how good the product is... the blood glucose control it offers and cost. today is the day: 04/19/16
2:00 PM PT MannKind to Discuss U.S. Commercialization Update of Afrezza - See more at: investors.mannkindcorp.com/events.cfm#sthash.6M0HQusl.dpuf We have seen the hiring. Cash will be addressed. (?) Afrezza pricing. (?) Update information on working with pharmacy managers and insurance coverage. (?)
Vdex, I know vdex is private entity, I see it as a distribution center. Want Afrezza, hop a flight.
The conference call, " MannKind to Discuss U.S. Commercialization Update of Afrezza " I do not expect any other aspects of MNKD business to be discussed. investors.mannkindcorp.com/events.cfm
Perhaps we get some information of the wrap up of the sanofi deal.
"a business model that will jump start the second launch of Afrrezza." 
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Post by kball on Apr 19, 2016 8:18:37 GMT -5
Spiro believes that at this point, MNKD is focused solely on developing a business model that will jump start the second launch of Afrrezza. Let's face reality, a successful launch and strategy will propel the share price. An unsuccessful launch will result in eventual doom. Spiro here, betting on the M & M boys ( Matt and Mike ) getting the job done. sure looks like the ground work is being completed. what we have going for us now is how good the product is... the blood glucose control it offers and cost. today is the day: 04/19/16
2:00 PM PT MannKind to Discuss U.S. Commercialization Update of Afrezza - See more at: investors.mannkindcorp.com/events.cfm#sthash.6M0HQusl.dpuf We have seen the hiring. Cash will be addressed. (?) Afrezza pricing. (?) Update information on working with pharmacy managers and insurance coverage. (?)
Vdex, I know vdex is private entity, I see it as a distribution center. Want Afrezza, hop a flight.
The conference call, " MannKind to Discuss U.S. Commercialization Update of Afrezza " I do not expect any other aspects of MNKD business to be discussed. investors.mannkindcorp.com/events.cfm
Perhaps we get some information of the wrap up of the sanofi deal.
"a business model that will jump start the second launch of Afrrezza."
The Inhale-a-mobile!
All that's missing is Afrezza users having an eat whatever u want picnic under that overhang
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Post by peppy on Apr 19, 2016 8:26:32 GMT -5
tail-gating I hope to do that at the fair. All you can eat free, when wearing a continuous glucose monitor.
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Post by lakon on Apr 19, 2016 11:05:08 GMT -5
I'd tailgate under that overhang any day...drinking, grilling, eating, and hitting Afrezza all day long...
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Post by lakon on Apr 19, 2016 11:26:22 GMT -5
lakon, can you explain why you think a superiority trial won't be done? My impression is that the trial design required for approval was complicated by Afrezza being a new drug and thereby posing a risk to patients if used in a non-standard way. Tinfoil hat conspiracies aside, I'd like to think we've moved on from there and the next trial can be designed to highlight Afrezza's advantages. It would be easy to do a superiority trial, the problem would be the time and the cost. The PK/PD studies support the new dosing regime and the trial protocol just needs to then be designed to incorporate that. Better, Faster, Cheaper is often a goal, but rarely has it ever been easy. That's why engineers always say, "Pick 2!" Obviously, we disagree. Time will prove it to us (in so many ways). Fortunately for me, you already made part of my argument. The easiest way for me to get my point across is to ask a question. Is Humulin superior to Humalog? It all depends how one defines superiority. In this case, one has to use the FDA's definition. Good luck. |
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Post by agedhippie on Apr 19, 2016 19:58:25 GMT -5
It would be easy to do a superiority trial, the problem would be the time and the cost. The PK/PD studies support the new dosing regime and the trial protocol just needs to then be designed to incorporate that. Better, Faster, Cheaper is often a goal, but rarely has it ever been easy. That's why engineers always say, "Pick 2!" Obviously, we disagree. Time will prove it to us (in so many ways). Fortunately for me, you already made part of my argument. The easiest way for me to get my point across is to ask a question. Is Humulin superior to Humalog? It all depends how one defines superiority. In this case, one has to use the FDA's definition. Good luck. Is Humulin superior to Humalog? If you have ever used Humulin you know the answer to that one  More seriously the answer is yes. They did the superiority trial back in the early 1990s. Superiority just means one drug was better than another drug with a certain confidence interval for the primary outcome measure. The drug company sponsoring the trial and not the FDA define what that measure is. With diabetes superiority is usually shorthand for A1c primary outcome but it doesn't have to be that at all. |
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Post by lakon on Apr 20, 2016 15:22:00 GMT -5
Better, Faster, Cheaper is often a goal, but rarely has it ever been easy. That's why engineers always say, "Pick 2!" Obviously, we disagree. Time will prove it to us (in so many ways). Fortunately for me, you already made part of my argument. The easiest way for me to get my point across is to ask a question. Is Humulin superior to Humalog? It all depends how one defines superiority. In this case, one has to use the FDA's definition. Good luck. Is Humulin superior to Humalog? If you have ever used Humulin you know the answer to that one More seriously the answer is yes. They did the superiority trial back in the early 1990s. Superiority just means one drug was better than another drug with a certain confidence interval for the primary outcome measure. The drug company sponsoring the trial and not the FDA define what that measure is. With diabetes superiority is usually shorthand for A1c primary outcome but it doesn't have to be that at all. Can you provide link(s) to the trial(s)? Thanks in advance. It would be great to capture on the board. I know the definition(s), but thanks for those who might not. Correct me if I'm wrong, but the FDA does have to approve the final trial design, right? At least, if you want it to be meaningful for changing the label... |
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Post by agedhippie on Apr 20, 2016 15:40:23 GMT -5
Is Humulin superior to Humalog? If you have ever used Humulin you know the answer to that one More seriously the answer is yes. They did the superiority trial back in the early 1990s. Superiority just means one drug was better than another drug with a certain confidence interval for the primary outcome measure. The drug company sponsoring the trial and not the FDA define what that measure is. With diabetes superiority is usually shorthand for A1c primary outcome but it doesn't have to be that at all. Can you provide link(s) to the trial(s)? Thanks in advance. It would be great to capture on the board. I know the definition(s), but thanks for those who might not. Correct me if I'm wrong, but the FDA does have to approve the final trial design, right? At least, if you want it to be meaningful for changing the label... There you go - lillytrials.com/results/Humalog.pdfThe FDA's role is to ensure that the risk to trial participants is minimized and that the standardized documentation is completed ( there is a description here). It is worth reading the Non-inferiority document since the introduction also discusses other trial types including superiority trials. If the documentation is completed and filed the label change can be supported provided the relevant outcomes are met. I am curious to see the filings for the 171 trial and what the protocols looked like. |
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Post by longinvstr on Apr 20, 2016 20:19:21 GMT -5
I'd tailgate under that overhang any day...drinking, grilling, eating, and hitting Afrezza all day long... Would that be called "Inhale gating?" |
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Post by mnholdem on Apr 20, 2016 21:44:01 GMT -5
I'd tailgate under that overhang any day...drinking, grilling, eating, and hitting Afrezza all day long... Would that be called "Inhale gating?" Actually, if one were to study Afrezza's PK/PD profile, you might come up with the phrase, "No-Tail"-gating. Maybe Jay might add that catch-phrase to the Afrezzamobile? |
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Post by sportsrancho on Apr 20, 2016 22:09:02 GMT -5
That is to good!! Please someone tell Jay!
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Post by jerrys on Apr 20, 2016 23:59:19 GMT -5
Can you provide link(s) to the trial(s)? Thanks in advance. It would be great to capture on the board. I know the definition(s), but thanks for those who might not. Correct me if I'm wrong, but the FDA does have to approve the final trial design, right? At least, if you want it to be meaningful for changing the label... There you go - lillytrials.com/results/Humalog.pdfThe FDA's role is to ensure that the risk to trial participants is minimized and that the standardized documentation is completed ( there is a description here). It is worth reading the Non-inferiority document since the introduction also discusses other trial types including superiority trials. If the documentation is completed and filed the label change can be supported provided the relevant outcomes are met. I am curious to see the filings for the 171 trial and what the protocols looked like. The protocol was summarized in the briefing document:
www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf
...pages 54-56.
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Post by agedhippie on Apr 21, 2016 8:00:29 GMT -5
Thanks. Looking at the document they recognize that Afrezza behaves differently and allow participents to titrate their dose to hit their targets, and also to handle corrections differently for optimal performance (Afrezza can correct after 90 minutes vs. at the next meal so 4 hours later) that should favor Afrezza. What I cannot see is any requirement for when to dose for the meal. It looks like the protocol permitted anything at that point which would be in-line with the self-titration. |
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