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Post by jjacobs122 on Dec 10, 2020 20:25:43 GMT -5
What are peoples thoughts on the earliest possible pediatric approval for afrezza?
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Post by goyocafe on Dec 10, 2020 21:12:43 GMT -5
2023
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Post by longliner on Dec 10, 2020 21:22:48 GMT -5
Could needle phobia make inhalation be considered as an unmet need?
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Post by mango on Dec 10, 2020 21:42:32 GMT -5
When we know the start date of Phase 3 we’ll have a timeline for approval.
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rwp
Newbie
Posts: 24 
Sentiment: Long
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Post by rwp on Dec 12, 2020 1:08:52 GMT -5
When we know the start date of Phase 3 we’ll have a timeline for approval. Approximately how long do you expect it to take from the start of Phase 3 to Approval? |
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Post by peppy on Dec 12, 2020 7:27:15 GMT -5
When we know the start date of Phase 3 we’ll have a timeline for approval. Approximately how long do you expect it to take from the start of Phase 3 to Approval? rwp, I will give it to you straight. Since 2016 there have been multiple projections for the trials that need to be done to start. MNKD hasn't had the money to run the trials. During the quarterly conference calls, they have put up the projections of study start time. The children have supposedly been being recruited for years now. I haven't looked at the stuff for a long time. clinicaltrials.gov/ct2/show/NCT02527265The results for the phase once is not posted here. No Study Results Posted on ClinicalTrials.gov for this Study |
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Deleted
Deleted Member
Posts: 0
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Post by Deleted on Dec 12, 2020 10:17:09 GMT -5
When we know the start date of Phase 3 we’ll have a timeline for approval. Per Mike it will take 2 years from the start of the trial. Mike has also said it they are looking for a partner to help fund it and eventually market to kids and the Type 2 Market. Mike said they want to design the trial cover all shortfalls of the previous trials. I believe the new partner will have serious input in the design and rollout. Hoping for a 1Q21 start. |
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Post by matt on Dec 12, 2020 13:56:13 GMT -5
When we know the start date of Phase 3 we’ll have a timeline for approval. Per Mike it will take 2 years from the start of the trial. Mike has also said it they are looking for a partner to help fund it and eventually market to kids and the Type 2 Market. Mike said they want to design the trial cover all shortfalls of the previous trials. I believe the new partner will have serious input in the design and rollout. Hoping for a 1Q21 start. Two years after start of trial is a minimum depending on what FDA asks for. There is that pesky trial that the company agreed to run on lung function that has never been completed, and while many think this is something MNKD will never have to address, FDA may think differently (they have a long memory). If FDA does give a pass on this requirement, and doesn't think of any new requirements, then two years is entirely plausible. I do not think it is feasible to find a partner that will market the drug to the pediatric and Type II segment unless than partner also has the Type I segment. There are several examples of companies that tried to co-market the exact same drug using two different marketing channels for different indications and all of these arrangements wound up a mess. Suffice it to say that keeping track of which dose goes to a Type I patient versus a dose to Type II is nearly impossible, and if the co-promoters do not coordinate pricing very carefully pharmacists and the payors rapidly figure out which channel is the cheapest and they buy all their product from the low cost option. That makes one partner very happy and one partner very unhappy which is why these deals tend to fall apart quickly. No partner is going to help pay for a trial unless they have significant say over the trial design and label claims. That is pretty normal in the industry. The difficulty will be finding a partner willing to take on Afrezza given the history with Sanofi. Lilly and Novo are not going to be volunteering to cannibalize their injectables market, and finding a third party that wants to jump into the pricing scrum around insulin products is going to be a real challenge. I don't think a 1Q21 start date is realistic given that the partner has yet to sign up. Once a partner is announced, it will be 3-6 months before the first patient is trialed because the trial has to be designed, submitted to FDA, investigators have to be recruited, the plan has to be submitted to the institutional review boards, and so on. None of that happens overnight, even with the most capable partner. |
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