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Post by orlon on Sept 6, 2017 15:31:52 GMT -5
Does anyone know when MNKD will find out about the label change?
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Post by babaoriley on Sept 6, 2017 15:41:04 GMT -5
Supposedly, reportedly, hopefully, by the end of this month.
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Post by therealisaching on Sept 11, 2017 12:52:24 GMT -5
Per Mike C. from the q2 earnings transcript:
First the label change has a couple aspects to it and I think about it in three steps one there is the ability to articulate that the drug starts working within five minutes. The second part is we can articulate that it is faster than the competition. And the third is asking for a different category altogether. The important of these commercially really vary in terms of impact now in the second half of 2017 but as we go in 2018 and beyond.
As repute to communicate we expect PDUFA approval by the end of Q3. So this will be a Q4 event in terms of launch and impact. Depending on which combination of those three activities happen really will depend on the upside in terms of the forecast and the accelerate growth that we expect post the label change.
So for example if we were to get a different category that opens up a lot of the managed care access, if we takes that out of the bucket that we’re currently restricted in by the competition. So we don’t always control the buckets they’re consumed by the PBMs that drive 70% of the units in the country that really opens that window a little bit. It also dramatically could change Medicare Part D coverage.
When it comes to the speed of onset saying we work within five minutes the reason that's important as we’re running these trials right now with DexCom and what you can see is within three dots on the DexCom you can see whether you got your appropriate dose we need to follow up the dose. Being able to have the clinical data that we kicked off coming out in time frame and read for us internally to know what the label change is going to be we are waiting to see a couple dots on their CGM which way did overshoot or undershoot for dosing in order to pull them back into time and range very quickly.
We expect that the five minutes claim to be in there the data supports that and something we’re excited about. The other thing I can tell you is when we shared that PK/PD curve with the physician and asked them what does this mean to you the five-minute onset meant more to the physician than we expected in terms of just understanding the PK/PD is a product the speed of onset, getting out of body fast and all the things that come without backing of insulin and injecting. So that really gave them some confidence around how to mince with a drug and what they can communicate to the patient's.
And then getting out of body faster and we know to make that claim is read our label today we say we get in the body faster, but we can't necessarily say we work any faster. And that’s been something that’s been bothering us since launch. And this to me is a very important label update is it really will allow to finally articulate the true profile of this product at least from the PK/PD. When you take that label change plus the work that Ray has been doing and his team that we’re really working on this one-two punch combination and when it comes to some of these things.
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Post by kc on Sept 11, 2017 13:18:26 GMT -5
That would be great to get a label designation that no other Insulin has. But you can expect that the Big Pharma boys will lobby the FDA to try and prevent that from happening. This is a war and they are in it to destroy the little company MannKind.
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Post by goyocafe on Sept 11, 2017 13:28:07 GMT -5
That would be great to get a label designation that no other Insulin has. But you can expect that the Big Pharma boys will lobby the FDA to try and prevent that from happening. This is a war and they are in it to destroy the little company MannKind. No one should know the FDA leanings in this matter until the decision is made (wishful thinking). That said, letters can obviously be sent in anticipation one way or the other by anyone (e.g. Skreli) I know we've all wanted to know for a while, and Mike clarified the requested changes during the last quarter call. This was a double edged sword since it gave anyone interested in writing a letter fodder for their lobbying efforts. We'll know soon enough. |
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Post by dreamboatcruise on Sept 11, 2017 13:34:10 GMT -5
That would be great to get a label designation that no other Insulin has. But you can expect that the Big Pharma boys will lobby the FDA to try and prevent that from happening. This is a war and they are in it to destroy the little company MannKind. Except for Novo may also be lobbying to create the new category of ultra-rapid... and if Fiasp qualifies, it seems hard to believe Afrezza would not. |
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Post by sportsrancho on Sept 11, 2017 13:38:21 GMT -5
What was your experience between Afrezza vs Faisp ? Would you try it if it happens to get US approval ? 7:06 AM · Sep 7, 2017 2 Retweets 1 Like Afrezzauser Afrezzauser afrezzauser· 13h Replying to @prajwolbhandari I was on the fiasp trials right after afrezza ...tail ends were the same as novolog and onset was just a few minutes faster. Tail ends kill |
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Post by joeypotsandpans on Sept 11, 2017 13:39:05 GMT -5
That would be great to get a label designation that no other Insulin has. But you can expect that the Big Pharma boys will lobby the FDA to try and prevent that from happening. This is a war and they are in it to destroy the little company MannKind. No one should know the FDA leanings in this matter until the decision is made (wishful thinking). That said, letters can obviously be sent in anticipation one way or the other by anyone (e.g. Skreli) I know we've all wanted to know for a while, and Mike clarified the requested changes during the last quarter call. This was a double edged sword since it gave anyone interested in writing a letter fodder for their lobbying efforts. We'll know soon enough. PWD can write letters too especially those that have had life changing experiences, same as Sam and the others did in person at the ADCOM, it was very compelling if you never saw it. That is why I posted this in the other (Dash Interesting) thread. Here it is in case you missed it: yesterday at 2:53am sportsrancho said: Some women on a diabetic form asked, can I drink and use Afrezza? Well just ask Laura K:-) The people I know personally on Afrezza either were or are under 18. Or smoke and use Afrezza. Or drink everyday. I don't know what was said because the video stops on me, but it's all a eye roller! ....Just try it, get a sample. It might make your whole life easier! You won't have to think about everything you put in your mouth! Camp with it. Keep it in your car. It doesn't go bad! Take it sitting at restaurant. No more hiding. Un-plug! Put a Dreamboat in your pocket:-) A unit is not the same as a unit. Take more. Don't make it so complicated. Kids pick it up right away because they don't over think it. "The new generation"!! Simple When you put it like that you know, you almost make it sound too good to be true. I was thinking the other day that an open letter to Scott Gottlieb detailing the history of what has taken place between the poorly set-up trials and CRL's that came about from his corrupt predecessor along with Sam possibly setting up something on his website with respect to validated testimonials from those that have been using it and how it has changed/improved their lives. It might just be considered when review of the label change takes place. Lord knows it couldn't hurt, rather may even be brought to light to the current admin. further reflecting the prior corrupt regime, they make talking to the Russians seem like a day in the park compared to the number of lives they have taken and continue to do so. Read more: mnkd.proboards.com/thread/8546/dash-interesting?page=1#ixzz4sOeRAJAsWhen you're in a war with the dark side, some truth and proven results in testimonials would be refreshing. I would hope that there were some already handed over when Mike and co. submitted but the open letter from those afflicted with the disease could have a decent wake up and smell the coffee effect  |
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Post by madog365 on Sept 11, 2017 13:56:50 GMT -5
Is the label change the KEY that will unlock all doors?
Let's assume the label change includes a brand new ULTRA rapid acting category of insulin for Afrezza. Mike mentioned this on the call today.
Potential Impacts:
Better tier 1/2 formulary coverage? Cheaper afrezza for patients, higher likelihood of prescription from docs?
Are they waiting for new FDA label to submit for international markets approval? A brand new class of insulin is more likely to get fast track approval in some jurisdictions.
A financial backer could be waiting to re-capitalize the company based on the new label designation? Why invest now when you can wait to see if new label is approved and makes the company more valuable?
End of September we will know
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Post by dreamboatcruise on Sept 11, 2017 14:07:58 GMT -5
Is the label change the KEY that will unlock all doors? Let's assume the label change includes a brand new ULTRA rapid acting category of insulin for Afrezza. Mike mentioned this on the call today. Potential Impacts: Better tier 1/2 formulary coverage? Cheaper afrezza for patients, higher likelihood of prescription from docs? Are they waiting for new FDA label to submit for international markets approval? A brand new class of insulin is more likely to get fast track approval in some jurisdictions. A financial backer could be waiting to re-capitalize the company based on the new label designation? Why invest now when you can wait to see if new label is approved and makes the company more valuable? End of September we will know The prospect of that... funding contingent on new category label, makes me very nervous. Hopefully the waiting (which it seems we are) is driven by MNKD rather than the prospective backer(s), and they have one or more options teed up and ready to go regardless of label outcome. |
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Post by joeypotsandpans on Sept 11, 2017 14:20:35 GMT -5
I have had a script for two years, how many others do you think are in the same boat that have UHC/OPTUM or some other ignorant ins. co. as their insurer. I would say there are quite a few especially the ones that "supposedly didn't renew for other reasons" as some would have you believe. When the dam dam (from Chevy Chase Vegas Vacation, one of the best scenes in the movie btw) wall breaks lets see where the script numbers go. It's (my script) up for renewal btw, have my appt. scheduled....I want insulin (monomeric), my kidney's are not big fans of metformin maybe UHC/OPTUM would prefer to start paying for dialysis if they want me to use the metformin option....hey whatever happened to the Cali nurses on this board, Lynn and Coco...hope they're doing well |
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Post by saxcmann on Sept 11, 2017 14:29:14 GMT -5
Is the label change the KEY that will unlock all doors? Let's assume the label change includes a brand new ULTRA rapid acting category of insulin for Afrezza. Mike mentioned this on the call today. Potential Impacts: Better tier 1/2 formulary coverage? Cheaper afrezza for patients, higher likelihood of prescription from docs? Are they waiting for new FDA label to submit for international markets approval? A brand new class of insulin is more likely to get fast track approval in some jurisdictions. A financial backer could be waiting to re-capitalize the company based on the new label designation? Why invest now when you can wait to see if new label is approved and makes the company more valuable? End of September we will know Ultra on label is KEY but Less Hypo opens the door! |
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Post by itellthefuture777 on Sept 11, 2017 16:01:41 GMT -5
That would be great to get a label designation that no other Insulin has. But you can expect that the Big Pharma boys will lobby the FDA to try and prevent that from happening. This is a war and they are in it to destroy the little company MannKind. All those Big pharma's insulin sales are flat..and not growing anytime soon...Mannkind however as trajectory..they will never see with their insulins..ever..so..one day..(the sooner the better) I can envision a bidding war~ |
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Post by itellthefuture777 on Sept 11, 2017 16:06:18 GMT -5
A few weeks..
No other insulin is monomeric..except what the healthy human produces naturally..
No other insulin is Ultra Rapid Acting in..and out...except what the healthy human produces naturally..
No other insulin reduces hypos by more then 60% when used with a Basal insulin (and the basal was noted as the reason for those because the FDA wouldn't allow a reduction in the basal by 20% because it was not on their label to allow it..but 60% reduction in hypos when used with Afrezza..is significant) I don't think Afrezza Used alone caused any hypos in type 2 on the zero carb diet study where they took a dose..and ate nothing..no hypos!! No other insulin study like this one..ever done..with any other insulin..hmm..stands out..
Patient outcomes..coupled with One Drop to demonstrate..and Dexcom..will be a basis for pricing in the future..patient outcomes in the real world..
Label change also helps with pricing for insurances..so all that is coming ...and partners...and more and more sales..and more advertisement..and journals..
and Friday is only...a few days away..can't wait!!
Um..also..would like to see..Superior Glucose Control on the label as well...as maybe a lower risk of hypos if used with a basal..icing on the cake..
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Post by golfeveryday on Sept 11, 2017 19:14:11 GMT -5
Is the label change the KEY that will unlock all doors? Let's assume the label change includes a brand new ULTRA rapid acting category of insulin for Afrezza. Mike mentioned this on the call today. Potential Impacts: Better tier 1/2 formulary coverage? Cheaper afrezza for patients, higher likelihood of prescription from docs? Are they waiting for new FDA label to submit for international markets approval? A brand new class of insulin is more likely to get fast track approval in some jurisdictions. A financial backer could be waiting to re-capitalize the company based on the new label designation? Why invest now when you can wait to see if new label is approved and makes the company more valuable? End of September we will know Ultra on label is KEY but Less Hypo opens the door! indeed it does... |
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