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Post by biotec on Sept 7, 2021 9:09:09 GMT -5
RTTnews FDA Calander shows that the market potential from Tyvaso DPI According to analysis says it has blockbuster sales potential? I don’t believe there are that many PAH patients. I think it will sell good but not blockbuster category. Any thoughts?
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Post by hellodolly on Sept 7, 2021 12:46:34 GMT -5
RTTnews FDA Calander shows that the market potential from Tyvaso DPI According to analysis says it has blockbuster sales potential? I don’t believe there are that many PAH patients. I think it will sell good but not blockbuster category. Any thoughts? I recently looked this up and saw that it is currently a $5B market that is expected to grow to over $8B+ by 2023. |
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Post by Thundersnow on Sept 7, 2021 13:32:28 GMT -5
RTTnews FDA Calander shows that the market potential from Tyvaso DPI According to analysis says it has blockbuster sales potential? I don’t believe there are that many PAH patients. I think it will sell good but not blockbuster category. Any thoughts? Tyvaso DPI will become a blockbuster drug. You will convert about 90% of existing PAH Patients and if you add ILD indication and hopefully COPD and IPF (?) and now you're talking about $2 -$3B in annual Revenues. Currently Tyvaso is $450M in Revs. This will not happen overnight but it will happen. That's why it's vital for Mike to bring this to FDA approval. |
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Post by letitride on Sept 7, 2021 16:18:37 GMT -5
As I remember it Tyvasso had no commercial viability at all when Martine first got her hands on it. I would say the glass is currently half full soon to be overflowing.
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Post by Chris-C on Sept 7, 2021 20:37:28 GMT -5
RTTnews FDA Calander shows that the market potential from Tyvaso DPI According to analysis says it has blockbuster sales potential? I don’t believe there are that many PAH patients. I think it will sell good but not blockbuster category. Any thoughts? Tyvaso DPI will become a blockbuster drug. You will convert about 90% of existing PAH Patients and if you add ILD indication and hopefully COPD and IPF (?) and now you're talking about $2 -$3B in annual Revenues. Currently Tyvaso is $450M in Revs. This will not happen overnight but it will happen. That's why it's vital for Mike to bring this to FDA approval.
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Post by Thundersnow on Sept 7, 2021 21:38:29 GMT -5
Tyvaso DPI will become a blockbuster drug. You will convert about 90% of existing PAH Patients and if you add ILD indication and hopefully COPD and IPF (?) and now you're talking about $2 -$3B in annual Revenues. Currently Tyvaso is $450M in Revs. This will not happen overnight but it will happen. That's why it's vital for Mike to bring this to FDA approval.
No shit sherlock - We know MNKD's responsibility but who has more to lose??? UTHR....NO MNKD's future is riding on this approval. If they get a CRL due to TS then NO ONE will touch MNKD or Technosphere. That is why Mike is focused on doing his part to get DPI approved. |
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Post by porkini on Sept 7, 2021 21:59:03 GMT -5
No shit sherlock - We know MNKD's responsibility but who has more to lose??? UTHR....NO MNKD's future is riding on this approval. If they get a CRL due to TS then NO ONE will touch MNKD or Technosphere. That is why Mike is focused on doing his part to get DPI approved. Really? Nice job missing the point completely, Graupel. The OP pointed out that YOU said: Tyvaso DPI will become a blockbuster drug. You will convert about 90% of existing PAH Patients and if you add ILD indication and hopefully COPD and IPF (?) and now you're talking about $2 -$3B in annual Revenues. Currently Tyvaso is $450M in Revs. This will not happen overnight but it will happen. That's why it's vital for Mike to bring this to FDA approval. So, just at first blush, 75% of what you said may have merit, but the last 25% implying "it's vital for Mike to bring this to FDA approval" is simply off base. The OP, Chris-C, is completely correct in pointing out that both companies have a stake in the outcome, but UTHR is the party who is on watch here, MNKD has only to play its role to perfection according to its agreement with UTHR. Other good things will follow. |
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Post by prcgorman2 on Sept 8, 2021 6:12:19 GMT -5
No shit sherlock - We know MNKD's responsibility but who has more to lose??? UTHR....NO MNKD's future is riding on this approval. If they get a CRL due to TS then NO ONE will touch MNKD or Technosphere. That is why Mike is focused on doing his part to get DPI approved. The bold statement seems like hyperbole. The FDA approval based on currently submitted information by UTHR may or may not happen. If it was guaranteed, the stock price of both UTHR and MNKD would both be higher than what they are right now. If approval is not forthcoming, it doesn’t mean that it will never be approved. I think it is a good assumption that UTHR and MNKD would continue to pursue approval, presumably through another, larger, more expensive, and more time-consuming, and successful, trial. For sure, there are those who would love to see TreT denied approval and are doing what they can to promote that outcome, and yes, it would be a blow to both MNKD and UTHR, but to state with finality, that TS technology would become anethema is an overstatement. Also, I don’t like how you addressed my friend ChrisC. Please try to be more respectful. |
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Post by akemp3000 on Sept 8, 2021 6:56:58 GMT -5
Considering; 1) the drug has been approved and in use for years, 2) the delivery method has been approved and in use for years, 3) the supporting scientific data is solid, 4) the trial results were exceptional with all participants electing to continue its use, and 5) Martine put up $105M to expedite this approval, does anyone seriously believe this is not going to be approved? Granted the trial was small and there is always the chance of nefarious action, but IMO, even calling this a NDA is a stretch and it's hard to imagine a CRL. We'll never know for sure until it happens but this needs to happen.
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Post by golfeveryday on Sept 8, 2021 7:06:12 GMT -5
Considering; 1) the drug has been approved and in use for years, 2) the delivery method has been approved and in use for years, 3) the supporting scientific data is solid, 4) the trial results were exceptional with all participants electing to continue its use, and 5) Martine put up $105M to expedite this approval, does anyone seriously believe this is not going to be approved? Granted the trial was small and there is always the chance of nefarious action, but IMO, even calling this a NDA is a stretch and it's hard to imagine a CRL. We'll never know for sure until it happens but this needs to happen. I’m sure UTHR consulted the FDA with the Trial design to ensure it was enough for approval. |
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Post by longliner on Sept 8, 2021 9:47:31 GMT -5
Considering; 1) the drug has been approved and in use for years, 2) the delivery method has been approved and in use for years, 3) the supporting scientific data is solid, 4) the trial results were exceptional with all participants electing to continue its use, and 5) Martine put up $105M to expedite this approval, does anyone seriously believe this is not going to be approved? Granted the trial was small and there is always the chance of nefarious action, but IMO, even calling this a NDA is a stretch and it's hard to imagine a CRL. We'll never know for sure until it happens but this needs to happen. I try to maintain a healthy skepticism regarding all FDA events / actions. That said, I expect approval in October. |
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Post by mnkdfann on Oct 2, 2021 21:32:11 GMT -5
So, I believe the FDA decision is anticipated by the end of the month.
What are expectations for the MNKD share price, in the cases of both approval and non-approval?
I wonder if an options straddle would be a good strategy about now.
I see the November 4.50 call and put each last traded at 0.55 and 0.65, respectively.
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Post by sportsrancho on Oct 3, 2021 12:20:11 GMT -5
pennystocks.com/featured/2021/10/03/5-penny-stocks-to-watch-this-week-potential-biotech-catalysts/What To Watch With MNKD Stock This Week This week and this month could be important for MannKind. First, on October 5, the company participates at the Lytham Partners Fall Investor Conference. CEO Michael Castagna, PharmD, will discuss different facets of the company. In addition, while a specific date wasn’t given, a September update discussed that FDA action on a New Drug Application (NDA) for Tyvaso DPI is expected this month. This comes after United Therapeutics submitted an NDA to the FDA seeking approval of Tyvaso DPI for treating adult patients with PAH and PH-ILD.
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Post by sportsrancho on Oct 3, 2021 12:34:48 GMT -5
So, I believe the FDA decision is anticipated by the end of the month. What are expectations for the MNKD share price, in the cases of both approval and non-approval? I wonder if an options straddle would be a good strategy about now. I see the November 4.50 call and put each last traded at 0.55 and 0.65, respectively. Just guessing below $3 and over $6 How many people are hedged with puts against a large share position? |
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Post by biotec on Oct 4, 2021 7:56:44 GMT -5
So, I believe the FDA decision is anticipated by the end of the month. What are expectations for the MNKD share price, in the cases of both approval and non-approval? I wonder if an options straddle would be a good strategy about now. I see the November 4.50 call and put each last traded at 0.55 and 0.65, respectively. Just guessing below $3 and over $6 How many people are hedged with puts against a large share position? |
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