List of Anticipated catalyst and time frame

[jjacobs122]

Anticipated catalyst and time frame
As prescriptions for afrezza basically have disappointed for so long I was curious what anticipated catalysts and time frame people feel might  finally positively impact this story

-Please comment on anticipated timeline for the drug to be made available for pediatric sale best case scenario

-Please comment on anticipated Timeline for United therapeutics Treponostil to be made available for sale best case scenario

are there any other positive catalysts?

[buyitonsale]

investors.mannkindcorp.com/events/event-details/mannkind-corporation-annual-meeting-stockholders-0



ir.unither.com/events-presentations

[radgray68]

Best guess? Small lifts if the Dexcom data impresses. Perhaps several ups and downs with upcoming news on Tre-T trials and Afrezza sales beats are possible. However, after that I'm looking for trial results using the new titration protocols. India, then U.S. Pediatric trials. So, nothing earth shattering until, I hate to say it but even with TreT .....2022?
That's why I'm just trading the inevitable fluctuations around a core for now.

[mytakeonit]

2022 is just 2 years away. You can buy into the core now ... or an apple in a short while ... OR, a huge watermelon later !!!

But, that's mytakeonit

[jjacobs122]

Thank you. On the pediatric trials, do we know when the drug can be marketed and sold for the pediatric population best guess date?

Also best guess date of sale for treponistil?

[MnkdWASmyRtrmntPlan]

Thanks to Mango, here are dates for peds trials completion date.


The Peds clinical trial is thought to be a major milestone and monumental event amongst both investors, and the MannKind team alike. I noticed that an update occurred yesterday, March 8th, 2020, and so I have included a link to the History of Changes in a side-by-side fashion with the previous date of changes for easy viewing.

Estimated Study Completion Date is January 2021, while the Estimated Primary Completion Date is July 2020.



Mango's Pediatric Trial post

mnkd.proboards.com/post/199858


Now, if the trial completion is January 2021, would the estimate for the first pediatric prescription sales be mid-2021?  
Will they also need to get insurance companies onboard for Peds, or will that be automatic, since insurance is approved for adults and now sales are approved for peds?
Another thought ... will approval for peds expedite Afrezza SoC?

[mnkdfann]

Jun 9, 2020 8:29:49 GMT -5 MnkdWASmyRtrmntPlan said:

Thanks to Mango, here are dates for peds trials completion date.
Now, if the trial completion is January 2021, any guesses on when the first pediatric prescription will be sold?


The Peds clinical trial is thought to be a major milestone and monumental event amongst both investors, and the MannKind team alike. I noticed that an update occurred yesterday, March 8th, 2020, and so I have included a link to the History of Changes in a side-by-side fashion with the previous date of changes for easy viewing.

Estimated Study Completion Date is January 2021, while the Estimated Primary Completion Date is July 2020.

Mango's Pediatric Trial post

mnkd.proboards.com/post/199858

FWIW, as noted in the next posts in the thread, the update was actually a year previous. In 2019. Mango made a typo. No updates since. As was noted by another poster: "For a major milestone and monumental event, pretty awful that there have been no updates in over a year to this. Every previous year there were at least 5 updates." 

mnkd.proboards.com/thread/11816

[jjacobs122]

Thanks

Anyone on Treponostil?

[matt]

Jun 9, 2020 8:29:49 GMT -5 MnkdWASmyRtrmntPlan said:

Now, if the trial completion is January 2021, would the estimate for the first pediatric prescription sales be mid-2021?  
Will they also need to get insurance companies onboard for Peds, or will that be automatic, since insurance is approved for adults and now sales are approved for peds?
Another thought ... will approval for peds expedite Afrezza SoC?

Afrezza is not indicated for children so it cannot be sold for pediatric use until FDA grants a label change.  Obviously the hope is that this pediatric trial will be sufficient evidence to get FDA consent to amend the label, but that is not guaranteed.  Since this is a significant change to the label, the study results will undergo a significant review process.  If data collection is done January 2021, figure up to a year to compile the results and statistical analysis, write up an amendment to the drug application, submit it, and have FDA approve the label change.  I know that sounds like a lot of time, but there are a bunch of moving pieces in any trial and they all have to be completed before approval is granted.

Insurance companies that already cover Afrezza will likely cover pediatric use as well, but keep in mind that few insurance companies cover Afrezza as a Tier 1 or 2 drug so that requires the physician to go through a pre-approval process, and many don't cover it at all.  Pediatrics will be no different.

SoC is an entirely different kettle of fish, and one that is even more complicated than insurance to solve.  Changing clinical practice never happens quickly.