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Post by #NoMoreNeedles on Aug 16, 2017 3:42:29 GMT -5
Mike says: So you've heard a lot from all of us. I know the #1 question on your mind is capitalization of the company. What people need to understand is we have many options on the table as we think about sources of capital. We can issue debt, we can issue equity. We can do lease sale, lease buyback of our manufacturing plant out in Connecticut. There are development deals that Ray and I have been working on as well as international licensing opportunities.
When and where is the question now. Does Maxim Group know something we don't?
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Post by sportsrancho on Aug 16, 2017 7:01:00 GMT -5
They can't announce a deal before it's done. But they know when they expect it to be done. Everyone evolved knows.
I doubt the analysts know..
Mike said this is what we COULD do to extend the runway. Not this is what we have to do.
I bought another 1,000 shares yesterday on a dip. I'm not worried about dilution.
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Post by promann on Aug 16, 2017 7:07:10 GMT -5
They can't announce a deal before it's done. But they know when they expect it to be done. Everyone evolved knows. I doubt the analysts know.. Mike said this is what we COULD do to extend the runway. Not this is what we have to do. I bought another 1,000 shares yesterday on a dip. I'm not worried about dilution. Sports this is exactly what I was saying. What insiders know about the cash situation is different. Because they know what deals they can close but we don't. I believe they are in negotiations and trying to get the best deal possible with many options. |
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Post by #NoMoreNeedles on Aug 16, 2017 7:10:49 GMT -5
Are you anticipating a PIPE deal with Maxim?
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Post by peppy on Aug 16, 2017 7:13:47 GMT -5
Mike says: So you've heard a lot from all of us. I know the #1 question on your mind is capitalization of the company. What people need to understand is we have many options on the table as we think about sources of capital. We can issue debt, we can issue equity. We can do lease sale, lease buyback of our manufacturing plant out in Connecticut. There are development deals that Ray and I have been working on as well as international licensing opportunities.When and where is the question now. Does Maxim Group know something we don't?
MannKind's (MNKD) CEO Michael Castagna On Q2 2017 Results - Earnings Call Transcript seekingalpha.com/article/4096149-mannkinds-mnkd-ceo-michael-castagna-q2-2017-results-earnings-call-transcript
investors.mannkindcorp.com/events.cfm?EventType=Webcast
quote: There are development deals that Ray and I have been working on as well as international licensing opportunities. reply: ray just sold shares.
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Post by op2778 on Aug 16, 2017 7:13:48 GMT -5
All this stuff remember me of Pfeffer.....Probably u all have a short memory......
Am i the only one remembering Pfeffer during a CC: sorry, we´re late....because....uhm.....layers are telling me that i cannot disclose it yet, we still need some signature......And? Nothing happened.....he lies.......
I still remember when during a CC Pfeffer said: ABSOLUTELY NO DILUITION.....Well, CC ended and a PR with diluition came out.....
Probably i have a good memory....
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Post by mnholdem on Aug 16, 2017 7:23:03 GMT -5
Am I the only one who thinks there's a reason the Technosphere Trepostinil was accelerated in the MannKind pipeline with Ray stating they have a schedule for filing their IND with the FDA? Current treatments for PAH - Pulmonary Arterial Hypertension - can required patients chained to nebulizers and administering drugs 12-20 times a day.
There is definitely an unmet medical need in this area of medicine.  |
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Post by sportsrancho on Aug 16, 2017 8:11:18 GMT -5
All this stuff remember me of Pfeffer.....Probably u all have a short memory...... Am i the only one remembering Pfeffer during a CC: sorry, we´re late....because....uhm.....layers are telling me that i cannot disclose it yet, we still need some signature......And? Nothing happened.....he lies....... I still remember when during a CC Pfeffer said: ABSOLUTELY NO DILUITION.....Well, CC ended and a PR with diluition came out..... Probably i have a good memory.... I don't have a short memory. I don't compare the two. Mike has not said no dilution. He'll do what he needs to do to more the company forward. It would be nice if the timing of everything was perfect. But it never seems to be. Insurance is the bump in the road. As far as what mnholdem just said....exactly :-)) |
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Post by madog365 on Aug 16, 2017 8:15:31 GMT -5
Am I the only one who thinks there's a reason the Technosphere Trepostinil was accelerated in the MannKind pipeline with Ray stating they have a schedule for filing their IND with the FDA? Current treatments for PAH - Pulmonary Arterial Hypertension - can required patients chained to nebulizers and administering drugs 12-20 times a day.
There is definitely an unmet medical need in this area of medicine. I agree, it was all about EPI first in past calls and something has clearly changed. They mentioned that it is addressing an orphan condition and the economics of TREP-T sound promising. The positive FDA meeting may have swayed them to move in this direction - or perhaps interested partners for development. "For those of you who don't know, PAH is a type of high blood pressure affecting the arteries, or the lungs and right ventricle of the heart. It's estimated to impact about 250,000 individuals worldwide and it's considered in orphan condition. The market size exceeded about $6 billion in 2016, but there's considerable commercial potential through the premium price paid for PAH therapies. Currently, just to put some context around this, the current prostacyclins cost anywhere between $170,000 to $300,000 in a patient per year. The lifestyle and the quality of life for these patients is dramatically impacted by the current treatments out there. For those of you who don't know, you currently need to take roughly 12 to 20 inhalations a day through a nebulizer, and a machine to get your effective dose. And because of the complexity in the delivery, as well as the absorption of the product, it's very hard to get to the top end of therapeutic doses. We believe we have an opportunity here to deliver appropriate dosing in the current ranges of all upper dose ranges that will really help these patients receive tremendous benefit and get their disease under control. Today, the prostacyclins have about 45% market share, and we currently have labeled our Treprostinil, TREP-T, which will compete in the space. It is not the brand name, that is just our internal abbreviation as we refer to it. We're excited about this milestone in the company's history. We're excited for our development team to get to work, to start focusing on bringing this molecule forward. Many of you will probably ask me how we're able to afford to bring this forward. And I want to articulate that the early phase development of these programs do not cost a lot of money. They take more time. And so the capital put in towards this is worth it because it -- I don't want to lose another 3 to 6 to 9 months in time in a critical development pathway, which this, to me, can -- we have ensured time lines, but as we get through the single ascending dose study and build our confidence around the potential of this molecule, we will share updated time lines for potential launch. But obviously, we are moving fast because we believe there's an opportunity." Also a quote from Ray was also interesting: What is he talking about here? Is it RLS? "We also expect to be dosing our first subject with one of our investigational products for the first time in over a decade and this will occur in 2018. This is a quantum step forward for our development programs as well as for us as a company." |
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Post by #NoMoreNeedles on Aug 16, 2017 8:40:11 GMT -5
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Post by silentknight on Aug 16, 2017 8:53:56 GMT -5
Am I the only one who thinks there's a reason the Technosphere Trepostinil was accelerated in the MannKind pipeline with Ray stating they have a schedule for filing their IND with the FDA? Current treatments for PAH - Pulmonary Arterial Hypertension - can required patients chained to nebulizers and administering drugs 12-20 times a day.
There is definitely an unmet medical need in this area of medicine. I'll certainly applaud them for sidelining the Epi application in favor of Trepostinil. It makes more sense in every respect. You're addressing PAH through Technosphere application and administering the drug directly to the lungs for a disease that affects the lungs. It is a no-brainer. Not to mention that margins and treatment costs for PAH would likely provide MNKD with significantly more revenue if/when their new drug is approved and marketed and sales actually start to build. Epi always seemed like a bad idea to me and I'm glad they're moving on from it. |
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Post by casualinvestor on Aug 16, 2017 9:00:05 GMT -5
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Post by peppy on Aug 16, 2017 9:33:59 GMT -5
Am I the only one who thinks there's a reason the Technosphere Trepostinil was accelerated in the MannKind pipeline with Ray stating they have a schedule for filing their IND with the FDA? Current treatments for PAH - Pulmonary Arterial Hypertension - can required patients chained to nebulizers and administering drugs 12-20 times a day.
There is definitely an unmet medical need in this area of medicine. You're addressing PAH through Technosphere application and administering the drug directly to the lungs for a disease that affects the lungs. It is a no-brainer. Not to mention that margins and treatment costs for PAH would likely provide MNKD with significantly more revenue if/when their new drug is approved and marketed and sales actually start to build. Epi always seemed like a bad idea to me and I'm glad they're moving on from it. quote: I'll certainly applaud them for sidelining the Epi application in favor of Trepostinil. It makes more sense in every respect. margins and treatment costs for PAH would likely provide MNKD with significantly more revenue reply: heh. Agreed, it is a man's world.
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Post by joeypotsandpans on Aug 16, 2017 9:44:27 GMT -5
Am I the only one who thinks there's a reason the Technosphere Trepostinil was accelerated in the MannKind pipeline with Ray stating they have a schedule for filing their IND with the FDA? Current treatments for PAH - Pulmonary Arterial Hypertension - can required patients chained to nebulizers and administering drugs 12-20 times a day.
There is definitely an unmet medical need in this area of medicine. Trep-T as deemed orphan status as implied in the CC: www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/ucm2005525.htmOrphan Drug Modernization Plan On June 29, 2017 , the U.S. Food and Drug Administration unveiled a strategic plan to completely eliminate the agency’s existing orphan designation backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and respond to all new applications within 90 days of receipt during his testimony before a Senate subcommittee. That day may have had a lot to do with moving Trep-T up the development ladder and the referred to positive meeting with the FDA |
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Post by matt on Aug 16, 2017 11:23:25 GMT -5
Regarding TREP-T Anyone know how long these take to setup? With nothing filed will they be able to get results in time for this to be one of the two Sept announcements? I wouldn't hold my breath (no pun intended) for a September announcement unless you mean September 2018. Dose escalation studies with human subjects are considered a clinical trial (usually done as part of a Phase I or Phase II) and these require FDA review, approval by one or more Institutional Review Boards, the contracts office at the hospital or university, and then the data has to be collected and analyzed. Six months to a year is a realistic time frame to have a good understanding of the molecule. Unless the work started some time ago, September is too optimistic to see results. |
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