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Post by Clement on Jan 6, 2022 9:21:35 GMT -5
Maybe we will learn more on Thursday at the JP Morgan conference. Register to listen live at UTHR website. Upcoming Events Listen to webcast January 6, 2022 8:00 AM ET Fireside Chat with Martine Rothblatt and Michael Benkowitz Listened to the presentation this morning. Martine spent time talking about T-DPI and the progress made towards FDA approval. The 3rd party inspection process was moved to another location in record time at 69 days. They have not gotten a response from the FDA as of yet, so she could not give any other specifics related to Class I or Class II review. She expects a high conversion to T-DPI but not 100% because current patients are reluctant to switch therapies. She does expect 100% of new diagnosed patients to use the DPI version. She also spent time talking about supply chain concerns but emphasized that all of their products are made in the USA and they have stock piles of inventory. So I suspect that MNKD is producing lots of product for UTHR. The lawsuit with LQDA was brought up but didn’t say much let allow the layers to litigate the case. Martine said they are dealing with several issues of patent infringement by LQDA and that those issues are being addressed in several different fora. That was good news to me. |
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Post by Actual Investor on Jan 6, 2022 9:23:05 GMT -5
The question that most interests me is. who is the client? Clients provide the money and the push to get lawyers to write these types of letters. Any ideas on how to find out who initiated this action?
"Lassman Law+Policy is a boutique law firm located in Washington, D.C. that focuses on solving its clients’ most complicated FDA-related problems."
This is the 1st sentence on the law firm's web site. Lassman isn't doing this for grins. Some entity with adverse interests to UTHR and MNKD is behind this.
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Post by Clement on Jan 6, 2022 10:09:24 GMT -5
JP Morgan conference
January 6, 2022 8:00 AM ET
Fireside Chat with Martine Rothblatt and Michael Benkowitz
Thanks Boca for the summary!
But, dear fellow MNKD longs, I highly recommend that you go to the United Therapeutics website and listen to it yourself. I got a good feeling of confidence about the future of Tyvaso DPI.
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Post by mango on Jan 6, 2022 14:06:39 GMT -5
The question that most interests me is. who is the client? Clients provide the money and the push to get lawyers to write these types of letters. Any ideas on how to find out who initiated this action? "Lassman Law+Policy is a boutique law firm located in Washington, D.C. that focuses on solving its clients’ most complicated FDA-related problems." This is the 1st sentence on the law firm's web site. Lassman isn't doing this for grins. Some entity with adverse interests to UTHR and MNKD is behind this. Yes, Scott Lassman is a paid organizer in an anticompetitive scheme against MannKind and United Therapeutics. I filed a FOIA request with FDA back in July 2021 requesting any and all information pertaining to the CP, including the locked information and the client. I followed up with them in September and was told by the Lead Regulatory Counsel got the Center for Drug Evaluation and Research that I should expect a response in 18-24 months. Yes, you read that right! Whether or not FDA will give me that information remains to be seen. Doesn’t hurt to ask, though. Further, FDA is used to these anticompetitive schemes, and this will not hold. It will not hold because FDA has already approved our technology and the data for Tyvaso DPI conflicts with Mr. Lassman’s assertions. If FDA is an agency that makes decisions based on scientific data and observations then they will dismiss the CP. It’s nothing more than a ploy to slow down the regulatory approval process and adds unnecessary time commitments and constraints on FDA employees to investigate a bogus CP. |
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Post by buyitonsale on Jan 6, 2022 19:14:06 GMT -5
The UTHR call today was very reassuring from the Tyvaso DPI prospective. They achieved the NDA refiling in a record time and will be ready for inspections if needed. The commitment to the Tyvaso DPI product has been evident throughout this interview. They are expecting to triple Tyvaso patients by 2025 (combination of legacy and DPI).
When Martine was asked about Class 1 or 2 designation of refiling, "we are waiting for a bureaucratic step at the FDA... we should know that within a month or so". Then a wry smile followed...
I completely support any resentment toward FDA that Martine may have, especially since Tyvaso DPI is a lifestyle changing product for PAH patients and it did not deserve a CRL over a technicality.
Tyvaso DPI is "totally queued up for imminent approval", "for group 1 and group 3".
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Post by sellhighdrinklow on Jan 6, 2022 22:07:46 GMT -5
The question that most interests me is. who is the client? Clients provide the money and the push to get lawyers to write these types of letters. Any ideas on how to find out who initiated this action? "Lassman Law+Policy is a boutique law firm located in Washington, D.C. that focuses on solving its clients’ most complicated FDA-related problems." This is the 1st sentence on the law firm's web site. Lassman isn't doing this for grins. Some entity with adverse interests to UTHR and MNKD is behind this. Yes, Scott Lassman is a paid organizer in an anticompetitive scheme against MannKind and United Therapeutics. I filed a FOIA request with FDA back in July 2021 requesting any and all information pertaining to the CP, including the locked information and the client. I followed up with them in September and was told by the Lead Regulatory Counsel got the Center for Drug Evaluation and Research that I should expect a response in 18-24 months. Yes, you read that right! Whether or not FDA will give me that information remains to be seen. Doesn’t hurt to ask, though. Further, FDA is used to these anticompetitive schemes, and this will not hold. It will not hold because FDA has already approved our technology and the data for Tyvaso DPI conflicts with Mr. Lassman’s assertions. If FDA is an agency that makes decisions based on scientific data and observations then they will dismiss the CP. It’s nothing more than a ploy to slow down the regulatory approval process and adds unnecessary time commitments and constraints on FDA employees to investigate a bogus CP. 18-24 months???. This is obvious corruption. There is no way that a response could not happen within 72 hours. Request as " Immediate Resonse" and that you are with the media. |
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Post by boca1girl on Jan 18, 2022 10:01:14 GMT -5
My guess is approval June 27, 2022. 6 months from resubmission. My assumption is priority review still applies and thus 6 months. Also early summer as Martine stated. I will counter with a two month review and approval in March. I guessed the Class I review correct. I hope the approval comes early in Feb rather than closer to March. nxc2 - Other than the obvious benefit to MNKD, do I win anything with my counter to your position? 😎 |
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Post by akemp3000 on Jan 18, 2022 11:29:42 GMT -5
Nicely played Boca1girl. I'm hoping you win millions  |
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Post by akemp3000 on Jan 18, 2022 11:45:52 GMT -5
Now that we expect an early decision, it's possible there could be more to this than meets the eye. By this, there could be a behind the scenes agreement in place for something that gets triggered with the FDA approval. It could be anything from a milestone payment, to a buy-in, a buy-out, a new UTHR molecule announcement or an elevated partnership of some type. To be sure, this is clearly wild speculation as opposed to a prediction...just a fun thought while we wait.
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Post by peppy on Jan 18, 2022 12:05:15 GMT -5
Now that we expect an early decision, it's possible there could be more to this than meets the eye. By this, there could be a behind the scenes agreement in place for something that gets triggered with the FDA approval. It could be anything from a milestone payment, to a buy-in, a buy-out, a new UTHR molecule announcement or an elevated partnership of some type. To be sure, this is clearly wild speculation as opposed to a prediction...just a fun thought while we wait. I think what we know will happen is MNKD market cap should go up as MNKD will now turn profitable. The secret molecule is interesting. |
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Post by Deleted on Jan 18, 2022 12:57:22 GMT -5
Now that we expect an early decision, it's possible there could be more to this than meets the eye. By this, there could be a behind the scenes agreement in place for something that gets triggered with the FDA approval. It could be anything from a milestone payment, to a buy-in, a buy-out, a new UTHR molecule announcement or an elevated partnership of some type. To be sure, this is clearly wild speculation as opposed to a prediction...just a fun thought while we wait. You're absolutely correct.....MNKD gets access to $60M from their MID CAP Credit Line upon FDA approval. |
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Post by BlueCat on Jan 18, 2022 14:01:45 GMT -5
One can surely continue to hope.
For the long-timers here, I used the user name "Q2U" since I started and long before QAnon appeared. It was based on Star Trek, without any connection to this political/cultural group.
So for clarity, I have changed my user name and continue to hold long on MNKD and lurk here accordingly. GLTA.
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Post by mytakeonit on Jan 18, 2022 14:36:11 GMT -5
I'm still debating whether I need more than 1M shares  OH OH ... I guess GREED is starting to set in. But, that's mytakeonit Yeah peppy I know ... I have that 30 day rule ! |
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Post by buyitonsale on Jan 18, 2022 15:26:58 GMT -5
Mytakeonit is one of the few shorts I like on this forum, but I think his ambition to short more than 1 million shares is bit excessive and may require an intervention.  |
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Post by nxc2 on Jan 18, 2022 15:56:54 GMT -5
I will counter with a two month review and approval in March. I guessed the Class I review correct. I hope the approval comes early in Feb rather than closer to March. nxc2 - Other than the obvious benefit to MNKD, do I win anything with my counter to your position? 😎 I was going to say you won my respect but you have that already! I am happy you won! Will buy you a drink when we all meet! |
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OH OH ... I guess GREED is starting to set in.