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Post by lakers on Oct 1, 2016 0:40:50 GMT -5
Ray said "The first is Treprostinil for pulmonary arterial hypertension, PAH. PAH is a sizeable market expected to reach $10 billion by 2020. Treprostinil, a prostacyclin vasodilator is currently available in several formulations. However, these often carry a significant burden. This often leads to poor compliance and poor clinical outcomes. Our Tresprostinil program is in the early technical assessment phase. Preclinical is expected to begin in the second quarter of 2016 followed by clinical trials beginning in first quarter of 2017. We are actively looking for a development partner for this program. Ideally, the partner would be companies that already are active in this space." Competitor is United Therapeutics. The first product to look at is Remodulin, where 7 out of 10 patients on continuous PAH therapy are prescribed this drug. It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion. A drug they market under the name Tyvaso. And guess how Tyvaso is dosed? If you guessed that it is dosed with a United Therapeutics inhaler---BINGO! If you guessed it's treprostinil for PAH, then you get to move to the head of the class. Tyvaso has $450 M/yr run rate. Injected Remodulin has $650M/yr run rate. If the bong-like Tyvaso can sell well, why can't TS PAHale succeed if a reliable partner is found? Tyvaso had to go through the same 5-yr lung and 2-yr pediatric trials as Afrezza will. Somehow, UT marketed it well and made it a success. Mnkd needs to learn from the United Therapeutic Master. ir.unither.com/releasedetail.cfm?ReleaseID=981603Picture of the huge Tyvaso bong. www.tyvaso.com/hcp/dosage-administration/tyvaso-inhalation-system
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Post by Deleted on Oct 1, 2016 2:00:21 GMT -5
You're right on point. The problem is not whether MannKind's tech can accomplish this and everything else. The problem is Afrezza is the only physical example MannKind can present right now. That is why I strongly believe in RLS. MannKind said themselves (along the lines of) they did the deal because of how attractive it was from a business standpoint and how it will showcase the versitility of Technosphere, thus, creating the awareness and recognition it needs to do all of these things. That's just my thought on it.
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Post by lakon on Oct 1, 2016 4:19:27 GMT -5
If I was in charge of long-term strategy: ...a partnership with www.unither.com/ would change everything overnight in my opinion... Bringing in another billionaire with connections is going to be a big STFU to the naysayers. I'm still optimistic about the possibility of this happening within a year. If not them, the second best option is a big player who wants to compete with them, not good for UTHR, so... www.tyvaso.com/dtc (c'mon Technosphere blows the doors off theirs) www.unither.com/pipeline.html (inhale anti-rejection drugs for their organs)
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Post by lakers on Oct 1, 2016 8:53:20 GMT -5
It is truly a tragedy that with three different CEOs, Mnkd has not figured out how to monetize the TS and a bunch of patents. Instead, they blindly put all eggs in one basket. With $2.6B sunk over 10 years, Mnkd could have come up with multiple ground breaking products as RLS has staked out.
It's sad that they can only come up with Afrezza and fumbled it big time.
Mnkd didn't understand the word diversification.
Dr Solomon must have disagreed with Al about putting all eggs in one basket and left Mnkd.
Ditto Andrea Leone-Bay to join RLS.
It's time for RLS's backers to pump money into Mnkd for < 50% stake, reverse merge RLS into Mnkd to fully benefit from NOL, install their own CEO and Dirs.
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Post by dictatorsaurus on Oct 1, 2016 9:04:08 GMT -5
It is truly a tragedy that with three different CEOs, Mnkd has not figured out how to monetize the TS and a bunch of patents. Instead, they blindly put all eggs in one basket. With $2.6B sunk over 10 years, Mnkd could have come up with multiple ground breaking products as RLS has staked out. It's sad that they can only come up with Afrezza and fumbled it big time. Mnkd didn't understand the word diversification. Dr Solomon must have disagreed with Al about putting all eggs in one basket and left Mnkd. Ditto Andrea Leone-Bay to join RLS. It's time for RLS's backers to pump money into Mnkd for < 50% stake, reverse merge RLS into Mnkd to fully benefit from NOL, install their own CEO and Dirs. But we don't even know who RLS is or what their plans are.
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Post by Deleted on Oct 1, 2016 9:04:22 GMT -5
It is truly a tragedy that with three different CEOs, Mnkd has not figured out how to monetize the TS and a bunch of patents. Instead, they blindly put all eggs in one basket. With $2.6B sunk over 10 years, Mnkd could have come up with multiple ground breaking products as RLS has staked out. It's sad that they can only come up with Afrezza and fumbled it big time. Mnkd didn't understand the word diversification. Dr Solomon must have disagreed with Al about putting all eggs in one basket and left Mnkd. Ditto Andrea Leone-Bay to join RLS. It's time for RLS's backers to pump money into Mnkd for < 50% stake, reverse merge RLS into Mnkd to fully benefit from NOL, install their own CEO and Dirs. Do I hear a change in the tone towards management? They sure didn't know what they are doing . True leaders and management have a vision into the next decade always
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Post by lakon on Oct 2, 2016 8:35:37 GMT -5
It is truly a tragedy that with three different CEOs, Mnkd has not figured out how to monetize the TS and a bunch of patents. Instead, they blindly put all eggs in one basket. With $2.6B sunk over 10 years, Mnkd could have come up with multiple ground breaking products as RLS has staked out. It's sad that they can only come up with Afrezza and fumbled it big time. Mnkd didn't understand the word diversification. Dr Solomon must have disagreed with Al about putting all eggs in one basket and left Mnkd. Ditto Andrea Leone-Bay to join RLS. It's time for RLS's backers to pump money into Mnkd for < 50% stake, reverse merge RLS into Mnkd to fully benefit from NOL, install their own CEO and Dirs. Do I hear a change in the tone towards management? They sure didn't know what they are doing . True leaders and management have a vision into the next decade always The fat lady has not sung yet. Just because you don't know or understand the strategy does not mean that there is no strategy. There is clearly a vision since day one. MNKD started out with a powerful idea, and they began to diversify. The diversification was put on hold due to the CRL's and cash situation. They are now restarting their diversification, but without a successful launch of Afrezza, it won't matter. Therefore, the focus is on Afrezza, and rightly so. Al was still the smartest in the room and a proven winner. He was known for 11 year plans. I seriously doubt that they were just winging it all these years. MNKD had a plan, but things do not always go accordingly. MNKD has a plan, and they are executing it. Time will tell if the plan is successful. Even if the plan is good, there are no guarantees of success, like most things in life, chance and friends/enemies play a role, but then again, so does dumb luck. I'll bet on intelligent planning in the absence of good luck. Hope our luck changes too, but betting on a plan.
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Post by nimrod71 on Oct 2, 2016 8:45:17 GMT -5
If I was in charge of long-term strategy: ...a partnership with www.unither.com/ would change everything overnight in my opinion... Bringing in another billionaire with connections is going to be a big STFU to the naysayers. I'm still optimistic about the possibility of this happening within a year. If not them, the second best option is a big player who wants to compete with them, not good for UTHR, so... www.tyvaso.com/dtc (c'mon Technosphere blows the doors off theirs) www.unither.com/pipeline.html (inhale anti-rejection drugs for their organs)
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Post by nimrod71 on Oct 2, 2016 8:49:25 GMT -5
Long term strategy - um where is that money coming from? Matt said pretty much everything is on hold waiting for afrezza to carry the load. Matt has put all his eggs into one basket right now, everything else is on the back burner.
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Post by lakers on Nov 16, 2016 3:25:42 GMT -5
Next up is PAHale=Treprostinil+PDE5 inhibitor (Viagra®) Abstract Background: Inhaled treprostinil was recently developed for the treatment of pulmonary arterial hypertension. We investigated the safety and acute haemodynamic effects of the combination oral sildenafil and inhaled treprostinil in an open label study in patients with precapillary pulmonary hypertension. Methods and Patients: Inhaled nitric oxide (20 ppm; n=50), sildenafil (50mg; n=50) and inhaled treprostinil (15μg; n=25 or 30μg; n=25) were applied in subsequent order during right heart catheter investigation to consecutive patients with pulmonary arterial hypertension (PAH; n=28), non-operable chronic thromboembolic pulmonary hypertension (CTEPH; n=17) and pulmonary fibrosis associated pulmonary hypertension (n=5). Results: Inhaled nitric oxide reduced pulmonary vascular resistance (PVR) to 87.3 ± 5.1% of baseline values, reduced mean pulmonary arterial pressure (PAP) to 89.7 ± 3.5% and increased cardiac output (CO) to 102.4 ± 2.9%. Sildenafil reduced PVR to 80.1 ± 5.0%), mPAP to 86.5 ± 2.9 and increased CO to 103.8 ± 3.2%. Treprostinil, inhaled one hour after sildenafil, reduced PVR to 66.3 ± 3.8%, mPAP to 77.8 ± 3.3%, and increased CO to 107.1 ± 3.3% (mean ± 95% confidence interval). Subgroup analysis showed similar acute haemodynamic effects in PAH and CTEPH patients. Ventilation/perfusion distribution measurement in six patients with pre-existing gas exchange limitations was not changed by sildenafil and treprostinil. Relevant side effects were not observed. Conclusion: The combination of sildenafil and inhaled treprostinil was well tolerated and induced additive, pulmonary selective vasodilatation in pulmonary hypertension patients. This could be of relevance also for long term treatment of PAH and CTEPH patients. Acute effects of the combination of sildenafil and inhaled treprostinil on haemodynamics and gas exchange in pulmonary hypertension Drugs Treprostinil sodium was obtained from LungRX (Silver Spring, USA) as part of a clinical research collaboration. Sildenafil (Viagra®) is commercially available (Pfizer) and was obtained via the institutional pharmacy. Nitric oxide gas (2000ppm in nitrogen) was obtained from Linda AG (Pullach, Germany) and dosed to achieve an inspiratory concentration of 20-40 ppm. hal.archives-ouvertes.fr/hal-00499160/documentSildenafil, a PDE5 inhibitor, in the treatment of pulmonary hypertension www.tandfonline.com/doi/full/10.1586/14779072.4.3.293?scroll=top&needAccess=true
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Post by sweedee79 on Nov 16, 2016 12:24:36 GMT -5
It is truly a tragedy that with three different CEOs, Mnkd has not figured out how to monetize the TS and a bunch of patents. Instead, they blindly put all eggs in one basket. With $2.6B sunk over 10 years, Mnkd could have come up with multiple ground breaking products as RLS has staked out. It's sad that they can only come up with Afrezza and fumbled it big time. Mnkd didn't understand the word diversification. Dr Solomon must have disagreed with Al about putting all eggs in one basket and left Mnkd. Ditto Andrea Leone-Bay to join RLS. It's time for RLS's backers to pump money into Mnkd for < 50% stake, reverse merge RLS into Mnkd to fully benefit from NOL, install their own CEO and Dirs. Do I hear a change in the tone towards management? They sure didn't know what they are doing . True leaders and management have a vision into the next decade always My opinion is that Al was overconfident about Afrezza's marketing success... I don't think that he saw what was coming at all ... ... nor did we
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Post by Deleted on Nov 16, 2016 14:59:29 GMT -5
Retail didnt Smart money certainly did
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Post by mango on Nov 17, 2016 3:14:23 GMT -5
It is truly a tragedy that with three different CEOs, Mnkd has not figured out how to monetize the TS and a bunch of patents. Instead, they blindly put all eggs in one basket. With $2.6B sunk over 10 years, Mnkd could have come up with multiple ground breaking products as RLS has staked out.It's sad that they can only come up with Afrezza and fumbled it big time. Mnkd didn't understand the word diversification. Dr Solomon must have disagreed with Al about putting all eggs in one basket and left Mnkd. Ditto Andrea Leone-Bay to join RLS. It's time for RLS's backers to pump money into Mnkd for < 50% stake, reverse merge RLS into Mnkd to fully benefit from NOL, install their own CEO and Dirs. LOL. Surely you are not referring to drops, tabs, and pods...are you? Are you? Hello? Is that groundbreaking to you? Hello? Deny Ignorance.
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Post by mango on Nov 17, 2016 3:18:50 GMT -5
Do I hear a change in the tone towards management? They sure didn't know what they are doing . True leaders and management have a vision into the next decade always My opinion is that Al was overconfident about Afrezza's marketing success... I don't think that he saw what was coming at all ... ... nor did we I don't think anyone saw Teuza either and look what happened. They shut down the websites. Alfred Mann (and I take this statement from a friend) always had a "10 year year plan" aka knew WTF he was doing. Why do you think he only partners with private companies? Because he DESPISES big pharma. Why do you think he invested so much into Israel and AMIT? Because he DESPISES big pharma. Sanofi was out of desperation and nothing else. Welp, they got their karma, ammiright?
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Post by mango on Nov 17, 2016 3:20:44 GMT -5
It is truly a tragedy that with three different CEOs, Mnkd has not figured out how to monetize the TS and a bunch of patents. Instead, they blindly put all eggs in one basket. With $2.6B sunk over 10 years, Mnkd could have come up with multiple ground breaking products as RLS has staked out. It's sad that they can only come up with Afrezza and fumbled it big time. Mnkd didn't understand the word diversification. Dr Solomon must have disagreed with Al about putting all eggs in one basket and left Mnkd. Ditto Andrea Leone-Bay to join RLS. It's time for RLS's backers to pump money into Mnkd for < 50% stake, reverse merge RLS into Mnkd to fully benefit from NOL, install their own CEO and Dirs. Do I hear a change in the tone towards management? They sure didn't know what they are doing . True leaders and management have a vision into the next decade always Like Alfred Mann, you FUD.
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