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Post by cppoly on Jul 11, 2022 15:03:55 GMT -5
Sure we can wait till the upcoming earnings call in August, but what are the expected catalysts that were/are supposed to happen by now or relatively soon?
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Post by akemp3000 on Jul 11, 2022 16:25:11 GMT -5
IMO, there's no other catalyst that comes close to the importance of the UTHR approval and the anticipated jump in revenue. Aside from that, there's numerous other potential catalysts ongoing but can't think of any that were supposed to happen by now or relatively soon. Suggestions would be welcome.
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Post by Clement on Jul 11, 2022 18:41:37 GMT -5
In another thread, first shipments of Tyvaso DPI were at the very end of June. So, it appears to me that the first hard evidence of significant sales will be in the November EC for Q3. I like what sr71 said about it in "Afrezza Script Counts ...".
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Post by akemp3000 on Jul 12, 2022 5:22:13 GMT -5
Agree that the forthcoming Q2 may not yet offer a good indication of sales...BUT...the revenue for manufacturing a lot of samples along with the early shipments will be reported which should hopefully provide an important boost for Mannkind. Am still wondering what is UTHR's marketing plan to get patients to switch over to DPI. It's certainly promoted on the website, just wondering if they have contacted ongoing users directly to promote the switch?
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Post by anderson on Jul 12, 2022 9:43:11 GMT -5
While not reported in the second quarter what is the chance in the Q&A UTHR will answer a question regarding Tyvaso DPI growth in July?
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Post by prcgorman2 on Jul 12, 2022 10:04:37 GMT -5
While not reported in the second quarter what is the chance in the Q&A UTHR will answer a question regarding Tyvaso DPI growth in July? In MNKD's earnings report? 0% chance.
Sorry. Couldn't resist. I think the chance the question will be asked is not 0% and assume Dr. Rothblatt would answer it loosely if asked.
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Post by winner on Jul 13, 2022 7:17:27 GMT -5
Excerpt from another board. Apparently M.C. is on record indicating there will be news forthcoming ~ Q-3. Does anybody know the significance of the below noted excerpt?
INHALED IMATINIB FOR PULMONARY HYPERTENSION Publication number: 20220152025 Abstract: Methods of treatment of pulmonary hypertension comprising dry powder inhalation administration of imatinib, a pharmaceutically acceptable salt, or a derivative thereof, are provided. Dry powder inhalable compositions comprising imatinib, a pharmaceutically acceptable salt, or a derivative thereof, are also provided as well as methods of making the
ame. ype: Application Filed: November 16, 2021 Publication date: May 19, 2022 Applicants: United Therapeutics Corporation, MannKind Corporation Inventors: Adam Marc Silverstein, Patrick Poisson, Ajay Keshava, John J. Freeman,, JR., James Mills
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Post by peppy on Jul 13, 2022 7:23:47 GMT -5
Excerpt from another board. Apparently M.C. is on record indicating there will be news forthcoming ~ Q-3. Does anybody know the significance of the below noted excerpt? INHALED IMATINIB FOR PULMONARY HYPERTENSION Publication number: 20220152025 Abstract: Methods of treatment of pulmonary hypertension comprising dry powder inhalation administration of imatinib, a pharmaceutically acceptable salt, or a derivative thereof, are provided. Dry powder inhalable compositions comprising imatinib, a pharmaceutically acceptable salt, or a derivative thereof, are also provided as well as methods of making the ame. ype: Application Filed: November 16, 2021 Publication date: May 19, 2022 Applicants: United Therapeutics Corporation, MannKind Corporation Inventors: Adam Marc Silverstein, Patrick Poisson, Ajay Keshava, John J. Freeman,, JR., James Mills Gleevec is a kinase inhibitor indicated for the treatment of: • Newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Follow-up is limited to 5 years (1.1) • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy (1.2) • Pediatric patients with Ph+ CML in chronic phase who are newly diagnosed or whose disease has recurred after stem cell transplant or who are resistant to interferon-alpha therapy. There are no controlled trials in pediatric patients demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival (1.3) • Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) (1.4) • Adult patients with myelodysplastic/ myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements (1.5) • Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c- Kit mutational status unknown (1.6) • Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown (1.7) • Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) (1.8) • Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9)
www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf
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Post by akemp3000 on Jul 13, 2022 8:11:26 GMT -5
In all seriousness, you people are so smart. Your posts and perspectives are greatly appreciated. Now I just need an interpreter to explain what this could mean for the company
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Post by LongMNKD on Jul 13, 2022 8:40:44 GMT -5
The nearest catalyst IMO is the reveal of the royalty number % at the next call
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Post by hellodolly on Jan 18, 2023 9:51:33 GMT -5
So, we have on deck in 2023/24, so far: PHIII Trials for Afrezza in Adults - India 1H 2023 PHIII Trials for Afrezza in Children - USA 1H 2024 PHI/IIb Trials with Partner RLS - Study completion March 2023 Anxiety Disorders Interventional Study with RLS - Study completion July 2023 Epilepsy PHII/III Study of Clofazimine Launch 2023 Second UTHR Compound announcement (suspect for Cystic Fibrosis CF) 2023 Maybe Hypertension (see above)?
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Post by akemp3000 on Jan 18, 2023 10:12:54 GMT -5
That's excellent hellodolly. Now if someone has the time and inclination, it would be fascinating to see perspectives of the possible significance of each and maybe even the next step time line added beneath each line item, even if it's just speculation. It's asking a lot but why not at least ask
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Post by phdedieu12 on Jan 27, 2023 8:53:18 GMT -5
Is anyone else as excited/anxious as I am to see the results of the upcoming earnings call? While I don't think we're at full speed just quite yet with Tyvaso, it should give us a nice picture on the rest of the year and I am hoping based on the guesses I have seen from many on the board, a positive earnings beat.
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Post by sportsrancho on Jan 27, 2023 9:06:20 GMT -5
We probably all have friends.. I for sure do, that don’t post on social media anywhere, that have been in Mannkind for a long time because we suggested it years ago …now is the time to get back in touch with those people and maybe suggest adding to their position in celebration of profitability. #GetTheChampagneOut
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Post by Deleted on Jan 27, 2023 9:13:55 GMT -5
Off topic. Sports, what's going on with UTHR this morning? Up 13.5 %
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