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Post by mnholdem on Jun 7, 2018 12:09:31 GMT -5
While I was at the corporate website's pipeline page downloading the graphic, I branched out and did a little more exploration of the R&D webpages. This is an interesting little nugget I dug up:
Diverse Compatibility
Our dry powder formulation technology is compatible with a diverse assortment of drugs over a broad range of physicochemical characteristics, including molecular weight (300 – 150,000 Daltons), structure (small molecules to monoclonal antibodies), charge, and hydrophilicity/hydrophobicity. Our dry powders are ideally suited to deliver drugs for local diseases, such asthma and COPD.
In addition, the use of our Technosphere technology for systemic conditions was validated by the FDA approval of AFREZZA® (insulin human) inhalation powder, and has also been demonstrated in clinical studies with Technosphere formulations of parathyroid hormone (PTH/Technosphere), salmon calcitonin (sCT/Technosphere), and glucagon-like peptide 1 (GLP-1/Technosphere).
Source: www.mannkindcorp.com/research-development/tech-platforms/dry-powder-formulation/
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I wasn't aware that there were clinical studies conducted for these three API.
I few years ago I wrote that if Afrezza is a golden egg, then Technosphere is the goose that laid it. These studies bolster my opinion that, based on Intellectual Property alone, the stock market has greatly undervalued this company.
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Post by sportsrancho on Jun 7, 2018 12:58:22 GMT -5
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Post by buyitonsale on Jun 7, 2018 12:59:50 GMT -5
From Q1 2018 MannKind Corp Earnings Call:
TreT/treprostinil Phase 1 single ascending dose study has started, and we are excited about that. As you may have seen last week, United Therapeutics did a deal for $200 million for a pump. We believe this asset is a significant opportunity for us. We're waiting for the Phase 1 read out. That will be Phase 3 ready as soon as we get those results.
We believe it's a 3 player market with intense competition for differentiation, and remain committed to treprostinil to demonstrate that we believe this will show differences in potential dosing and convenience in this category. It is something we are going to look to partner as we go forward so that we can continue to reinvest and capitalize the company and Afrezza.
Results will be available and analyzed mid to late year. And based on these timelines, we anticipate initiating a switch study comparing treprostinil Technosphere inhalation with the standard of care, which is nebulized treprostinil therapy. This will then proceed into a pivotal pharmacokinetic study, which is in this case a 505(b) pathway, what is necessary for Phase 3 development and ultimately the data that's required for a 505(b)(2) submission, which we anticipate in the latter half of 2020.
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Post by silentknight on Jun 7, 2018 13:01:37 GMT -5
do I remember correctly that when trepT suddenly replaced epi , some thought that it was because it was easier to partner or sale and that we might already have someone waiting to see if the product was safe. So, now that we proved that the product is safe, what are the chances that we sale the right instead of waiting the end of the studies and how much could it worth at this point? I posted some thoughts on this some time ago. Based on the pipeline graphics at the corporate website, one could surmise that MannKind already has a partner in negotiations for TreT. As you can see from the pipeline graphic (below), it's clearly indicated that Epinephrine Technosphere and Palonosetron Technosphere are "AVAILABLE FOR LICENSE". Why wouldn't the Trepostinil say the same thing if MannKind didn't already have a partner for it?
Wouldn't a partnership qualify as a material event and require a press release? If MNKD had a partner on the drug, I feel like we would have known by now.
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Post by sportsrancho on Jun 7, 2018 13:06:19 GMT -5
I posted some thoughts on this some time ago. Based on the pipeline graphics at the corporate website, one could surmise that MannKind already has a partner in negotiations for TreT. As you can see from the pipeline graphic (below), it's clearly indicated that Epinephrine Technosphere and Palonosetron Technosphere are "AVAILABLE FOR LICENSE". Why wouldn't the Trepostinil say the same thing if MannKind didn't already have a partner for it?
Wouldn't a partnership qualify as a material event and require a press release? If MNKD had a partner on the drug, I feel like we would have known by now. “In negotiations.” Not till they sign on the dotted line.
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Post by agedhippie on Jun 7, 2018 13:17:54 GMT -5
...
In addition, the use of our Technosphere technology for systemic conditions was validated by the FDA approval of AFREZZA® (insulin human) inhalation powder, and has also been demonstrated in clinical studies with Technosphere formulations of parathyroid hormone (PTH/Technosphere), salmon calcitonin (sCT/Technosphere), and glucagon-like peptide 1 (GLP-1/Technosphere).
That is the stand-out to me. Park your tanks squarely on Trulicity's lawn with an inhaled GLP-1.
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Post by boca1girl on Jun 7, 2018 13:41:55 GMT -5
...
In addition, the use of our Technosphere technology for systemic conditions was validated by the FDA approval of AFREZZA® (insulin human) inhalation powder, and has also been demonstrated in clinical studies with Technosphere formulations of parathyroid hormone (PTH/Technosphere), salmon calcitonin (sCT/Technosphere), and glucagon-like peptide 1 (GLP-1/Technosphere).
That is the stand-out to me. Park your tanks squarely on Trulicity's lawn with an inhaled GLP-1. Didn’t we give Sanofi first right of refusal for a GLP-1 product when we partnered with them for Afrezza?
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Post by joeypotsandpans on Jun 7, 2018 13:47:00 GMT -5
Oh, perhaps you weren't aware that Mike and David recruited a bunch of test subjects at the Annual Meeting - shareholders were falling over each other to volunteer! More importantly, it looks like they have taken a page from our illustrious leader (btw, don't take that too seriously NY Lefty, however, chameleon you can take the analogy serious ) about not telegraphing and using a little bit of the surprise factor, even good ole Spence was caught off guard, which is what I've mentioned before about those darn catalysts that come from left field and aren't or can never really be part of his "modeling". It's happened before and suspect it will happen many more times in the future. Biggest game of the year tonight Baba, win this one and the pressure gets a tad heavier on those red jersey's back in DC. (I would have use the VGK color font in bold but was put in the corner with 20 lashes for overdoing it previously but one can use your imagination, insert pic of hockey stick here
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Post by centralcoastinvestor on Jun 7, 2018 13:48:34 GMT -5
That is the stand-out to me. Park your tanks squarely on Trulicity's lawn with an inhaled GLP-1. Didn’t we give Sanofi first right of refusal for a GLP-1 product when we partnered with them for Afrezza? I believe we completely severed ties with Sanofi when we settled with them a couple of years ago. At this point, we have no ties to Sanofi. It was the best thing that could have happened to get away from that back stabbing, lying company. They almost killed MannKind off.
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Post by robbmo on Jun 7, 2018 13:55:16 GMT -5
34 pages of instructions. 16 accessories required to administer. Device maintenance. /facepalm And don't forget to wash your hands and use distilled water when mixing. :-)
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Post by robbmo on Jun 7, 2018 14:00:15 GMT -5
Oh, perhaps you weren't aware that Mike and David recruited a bunch of test subjects at the Annual Meeting - shareholders were falling over each other to volunteer! More importantly, it looks like they have taken a page from our illustrious leader (btw, don't take that too seriously NY Lefty, however, chameleon you can take the analogy serious ) about not telegraphing and using a little bit of the surprise factor, even good ole Spence was caught off guard, which is what I've mentioned before about those darn catalysts that come from left field and aren't or can never really be part of his "modeling". It's happened before and suspect it will happen many more times in the future. Biggest game of the year tonight Baba, win this one and the pressure gets a tad heavier on those red jersey's back in DC. (I would have use the VGK color font in bold but was put in the corner with 20 lashes for overdoing it previously but one can use your imagination, insert pic of hockey stick here And Mike receives his CEO of the Year award tomorrow. What timing!
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Post by sportsrancho on Jun 7, 2018 14:34:06 GMT -5
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Post by hellodolly on Jun 7, 2018 14:46:30 GMT -5
Upgrade should weigh in more tomorrow...
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Post by boca1girl on Jun 7, 2018 14:48:02 GMT -5
Is this the stimulus for the price to run up for another private placement? Based on the previous experience, is now the time to cash out at $5-6 and then hope to get back in at a lower price? Or will it be different this time? I’ll be kicking myself if I took profits and then the stock did not fall back. I think I will cash out my 2020 calls and consider selling shares in my IRAs to avoid capital gains. I’m sure the traders among us will sell, but how about the rest of the longs?
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Post by oldfishtowner on Jun 7, 2018 14:49:25 GMT -5
Oh, perhaps you weren't aware that Mike and David recruited a bunch of test subjects at the Annual Meeting - shareholders were falling over each other to volunteer! More importantly, it looks like they have taken a page from our illustrious leader (btw, don't take that too seriously NY Lefty, however, chameleon you can take the analogy serious ) about not telegraphing and using a little bit of the surprise factor, even good ole Spence was caught off guard, which is what I've mentioned before about those darn catalysts that come from left field and aren't or can never really be part of his "modeling". It's happened before and suspect it will happen many more times in the future. Biggest game of the year tonight Baba, win this one and the pressure gets a tad heavier on those red jersey's back in DC. (I would have use the VGK color font in bold but was put in the corner with 20 lashes for overdoing it previously but one can use your imagination, insert pic of hockey stick here Go MNKD! Go CAPS! (Sorry, but I couldn't let all this Vegas talk go unanswered.)
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