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Post by lennymnkd on Jan 14, 2020 11:24:16 GMT -5
CIGNA ceo on CNBC from conference... interesting take on Diabetes.. preventative approach.. to diabetes... open minded about it .. the right medicine in the equation.
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Post by mango on Jan 14, 2020 12:01:16 GMT -5
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Post by brotherm1 on Jan 14, 2020 12:30:18 GMT -5
Simply because this is the first we’ve heard about the stability testing. We had talked much before about completion this year and not about 2 1/2 years from now for commercialization Mango. Did they start the stabilization study?
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Post by mango on Jan 14, 2020 12:45:01 GMT -5
Simply because this is the first we’ve heard about the stability testing. We had talked much before about completion this year and not about 2 1/2 years from now for commercialization Mango. Did they start the stabilization study? I listened to the Q&A where Martine comments on it and it does sound like it’s been started already. I also emailed MannKind IR about it 10 minutes ago and will post the reply here (if I receive one).
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Post by compound26 on Jan 14, 2020 12:49:42 GMT -5
Simply because this is the first we’ve heard about the stability testing. We had talked much before about completion this year and not about 2 1/2 years from now for commercialization Mango. Did they start the stabilization study? I listened to the Q&A where Martine comments on it and it does sound like it’s been started already. I also emailed MannKind IR about it 10 minutes ago and will post the reply here (if I receive one). They must have started it. Based on the Q&A, my understanding is that this stability test needs 12-months to complete. I think they probably started the test sometime before end of the year 2019 and therefore the test will finish sometime before end of the year 2020. It appears the explanation at the following web page makes senses for our case: camargopharma.com/resources/blog/stability-requirements-in-the-505b2-space-why-what-when-how"For submission of the NDA, the requirement is for 6 months of data from product stored and tested under accelerated conditions (40°C/75%RH), and twelve months for the long-term studies (25°C/60%RH)." "Hurry up and wait. That’s the seemingly eternal impact of developmental stability on the new drug development process. The question always asked is: “How can the developer minimize the wait part?” At the top level you can’t. It will always take six months to get six months of data and twelve to get twelve. But you can lessen the impact with early, thorough planning, starting soon after the development of the initial Target Product Profile."
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Post by mango on Jan 14, 2020 12:53:59 GMT -5
I listened to the Q&A where Martine comments on it and it does sound like it’s been started already. I also emailed MannKind IR about it 10 minutes ago and will post the reply here (if I receive one). They must have started it. Based on the Q&A, my understanding is that this stability test needs 12-months to complete. I think they probably started the test sometime before end of the year 2019 and therefore the test will finish sometime before end of the year 2020. That is my thinking as well. I did specifically ask IR if this is a room temperature test. Hopefully someone will email me back later with some clarity.
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Post by mango on Jan 14, 2020 12:58:53 GMT -5
Simply because this is the first we’ve heard about the stability testing. We had talked much before about completion this year and not about 2 1/2 years from now for commercialization Mango. Did they start the stabilization study? Completion was always going to be this year, but obviously it will take a decent amount of time for FDA approval post-submission. I always thought commercialization Q4 2021-1H 2020 was the expected dates. I guess you were confused or misunderstood, unless you read or heard something entirely different, and in that case you should share it with all of us. Not trying to be rude, just don’t understand the confusion/frustration with the timeline...
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Post by rfogel on Jan 14, 2020 13:12:08 GMT -5
Liquidia is expected to file an NDA for its inhaled treprostinil this quarter. How much of a lead will that give them over tre-t? Has anyone compared trial results between the two drugs?
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Post by mango on Jan 14, 2020 15:06:52 GMT -5
Liquidia is expected to file an NDA for its inhaled treprostinil this quarter. How much of a lead will that give them over tre-t? Has anyone compared trial results between the two drugs? Liquidia will need to demonstrate superior efficacy compared with current standard of care if they expect to take a meaningful size of the market share. Based on a skimming of PRs from Liquidia, it appears they failed to demonstrate the above. Here’s a snippet of what Liquidia had to say about their Phase 3 results: “The two-month results of the INSPIRE trial are promising for patients with PAH. Inhaled therapy offers the benefit of getting drug directly to the lungs and we are encouraged that the safety, tolerability and quality of life metrics suggest that LIQ861 is an attractive and more convenient therapy versus the currently available inhaled therapies,” said Dr. Hill.
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Post by figglebird on Jan 14, 2020 15:31:32 GMT -5
That is not TRUE - a dpi treatment in this case lqda's appears to be a far preferable/better option to tyvasso nuebalizer in many ways - there are areas such as mobility dosing and ease of use that would count under pathway they are taking... that said are far more complicated issues at hand either way...
I suspect there will be legal arguments put forth by uthr(knowing their track record) which will be enforceable temporarily at the least - once lqda is filed or approved... will have to see..
In many ways the investment in mnkd is their ability to dominate this potentially budding tech improvement.
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Post by mango on Jan 14, 2020 15:45:16 GMT -5
That is not TRUE - a dpi treatment in this case lqda's appears to be a far preferable/better option to tyvasso nuebalizer in many ways - there are areas such as mobility dosing and ease of use that would count under pathway they are taking... that said are far more complicated issues at hand either way... I suspect there will be legal arguments put forth by uthr(knowing their track record) which will be enforceable temporarily at the least - once lqda is filed or approved... will have to see.. In many ways the investment in mnkd is their ability to dominate this potentially budding tech improvement. They needed to demonstrate superior efficacy if they expected to scoop up a meaningful size of the market share, which UT currently controls. Even the inhaler Liquidia uses is ridiculous and out-dated, bringing considerable drawbacks and limitations. Compared with MannKind’s, Liquidia made an enormous mistake trying to compete with a giant like UT and a marvel of engineering and innovation like MannKind. 🙂
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Post by figglebird on Jan 14, 2020 16:41:24 GMT -5
Yes - I agree their commercial prospects are questionable particularly the post inspection regulations that would be under scrutiny compared to ts and mnkd hardware... which as some may come to realize we have prepared for etc.
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Post by mango on Jan 14, 2020 18:47:35 GMT -5
As promised.
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Post by brotherm1 on Jan 14, 2020 23:55:29 GMT -5
Yes - I agree their commercial prospects are questionable particularly the post inspection regulations that would be under scrutiny compared to ts and mnkd hardware... which as some may come to realize we have prepared for etc. . What post inspection regulations are you referring to verse MNKD?
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Post by georgethenight2 on Jan 15, 2020 7:02:17 GMT -5
And where in FDA approval is ralinepag that UTHR paid Arena $1B for? I still think , and now more than ever, that UTHR bought Trepostinil from MNKD for a few beans just to shelve it. I cant believe that Martine would be such a cold heart b - - - h. She is going on record as being grateful to Mann for his efforts to help his daughter survive. Not to mention that Bruin alumni do not do that to one another. And while we might be desirous of her to play a more active role in insuring MNKD's survival, the reality is, she is extremely busy with her own company and dealings.
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