|
|
Post by veritasfiliatemporis on Apr 1, 2021 7:01:27 GMT -5
Buyitonsale, Looks like you were right, hhhhmmm I should read your posts more accurately instead of wasting time reading posts about VDEX..."I presume... David".
|
|
|
|
Post by veritasfiliatemporis on Apr 1, 2021 7:04:25 GMT -5
|
|
|
|
Post by buyitonsale on Apr 1, 2021 12:02:50 GMT -5
An early April surprise, that's great, as I was expecting it around April 16.
This PAH-ILD indication approval has been communicated by UT for a long time (since they applied in August 2020), nothing new here other than an early date.
I am very excited for Tyvaso DPI NDA to be filed shortly this month.
What a great partner UT has been so far!
One thing that all MNKD shareholders should be aware of is that UT will launch Tyvaso immediately for new ILD patients, and that means a current Tyvaso device. UT repeatedly said the new Tyvaso DPI device has many advantages and I hope when it's approved it will uptake quickly, but realize that all new ILD patients that start on old Tyvaso now will need to switch after DPI is approved.
As far as existing PAH Tyvaso patients, I believe those prescribers will be introduced to the new DPI device by the UT sales force as soon as it's approved and I expect a very high conversion rate. The portability and convenience of the new DPI device are too obvious.
Good things ahead!
|
|
|
|
Post by porkini on Apr 1, 2021 12:46:14 GMT -5
An early April surprise, that's great, as I was expecting it around April 16. This PAH-ILD indication approval has been communicated by UT for a long time (since they applied in August 2020), nothing new here other than an early date. I am very excited for Tyvaso DPI NDA to be filed shortly this month. What a great partner UT has been so far!One thing that all MNKD shareholders should be aware of is that UT will launch Tyvaso immediately for new ILD patients, and that means a current Tyvaso device. UT repeatedly said the new Tyvaso DPI device has many advantages and I hope when it's approved it will uptake quickly, but realize that all new ILD patients that start on old Tyvaso now will need to switch after DPI is approved. As far as existing PAH Tyvaso patients, I believe those prescribers will be introduced to the new DPI device by the UT sales force as soon as it's approved and I expect a very high conversion rate. The portability and convenience of the new DPI device are too obvious. Good things ahead! Does anyone else wonder if the UT sales force, when introducing the "new" DPI device to prescribers, will also mention it is the same (or extremely similar) to the device used for the inhalable insulin Afrezza? I wonder. Professional networking. Cross-pollination. |
|
|
|
Post by winner on Apr 9, 2021 6:54:09 GMT -5
Good morning one and all: UTHR will be spending 105 million dollars to expedite the approval process for Tyvaso DPI. I for one think it's odd that UTHR has allowed a full business week to lapse without submitting their request. Time is money. I.M.H.O. This press release has got to be imminent
|
|
|
|
Post by winner on Apr 12, 2021 8:18:30 GMT -5
Will this be the week? It is costing UTHR approx. 3.2 million dollars each and every week for the delay.
|
|
|
|
Post by celo on Apr 12, 2021 10:35:13 GMT -5
Will this be the week? It is costing UTHR approx. 3.2 million dollars each and every week for the delay. I do not follow but if you don't mind explaining in a little more depth. |
|
|
|
Post by bthomas55ep on Apr 12, 2021 10:59:59 GMT -5
An early April surprise, that's great, as I was expecting it around April 16. This PAH-ILD indication approval has been communicated by UT for a long time (since they applied in August 2020), nothing new here other than an early date. I am very excited for Tyvaso DPI NDA to be filed shortly this month. What a great partner UT has been so far!One thing that all MNKD shareholders should be aware of is that UT will launch Tyvaso immediately for new ILD patients, and that means a current Tyvaso device. UT repeatedly said the new Tyvaso DPI device has many advantages and I hope when it's approved it will uptake quickly, but realize that all new ILD patients that start on old Tyvaso now will need to switch after DPI is approved. As far as existing PAH Tyvaso patients, I believe those prescribers will be introduced to the new DPI device by the UT sales force as soon as it's approved and I expect a very high conversion rate. The portability and convenience of the new DPI device are too obvious. Good things ahead! Does anyone else wonder if the UT sales force, when introducing the "new" DPI device to prescribers, will also mention it is the same (or extremely similar) to the device used for the inhalable insulin Afrezza? I wonder. Professional networking. Cross-pollination. I have to believe saturation of the technology will be very synergistic once there are 2 or 3 drugs using the same technology. Validation in addition to confidence in the solution should create interest and demand to significantly increase the company growth rate. I like the focus on 100% execution to hit a home run with Tyvasso. No hiccups and things should build on that foundation. |
|
|
|
Post by winner on Apr 12, 2021 11:05:07 GMT -5
Hi Celo
I should have worded the previous two messages differently. It is common knowledge in the public forum that UTHR will be spending 105 million dollars to expedite the approval of Tyvaso DPI. Approval can be received in 8 months as opposed to the normal 12 month time frame. From what I understand (I could be wrong) UTHR is spending this significant amount of money to simply have an additional 4 months to have their product(s) available for patients to make use of, prior to competitors similar products coming to market.
In reality, the total loss incurred by UTHR in delaying their approval request is an unknown. The eight month time frame does not start until UTHR submits their request. Each and every week that UTHR delays in submitting their request, competitors gain an additional week to get their product(s) to market.
I.M.H.O., we will see a significant increase in share price when UTHR makes the request to the FDA indicating they will be making use of MNKD to manufacture and provide the whistle to administer Tyvaso DPI. Please keep in mind, I have been wrong more times then not. L.O.L.
Best of luck to all MNKD equity shareholders.
|
|
|
|
Post by mymann on Apr 12, 2021 12:29:14 GMT -5
Technophere, Microsoft windows operating system for medication delivery system.
|
|
|
|
Post by cedafuntennis on Apr 12, 2021 12:42:31 GMT -5
Could you please elaborate?
|
|
|
|
Post by mymann on Apr 12, 2021 12:50:20 GMT -5
RLS, UTHR, and one more drug company, would show the rest of drug industry that MNKD is here to stay and play in the sand box with big boys.
|
|
|
|
Post by sportsrancho on Apr 12, 2021 13:37:34 GMT -5
Hi Celo I should have worded the previous two messages differently. It is common knowledge in the public forum that UTHR will be spending 105 million dollars to expedite the approval of Tyvaso DPI. Approval can be received in 8 months as opposed to the normal 12 month time frame. From what I understand (I could be wrong) UTHR is spending this significant amount of money to simply have an additional 4 months to have their product(s) available for patients to make use of, prior to competitors similar products coming to market. In reality, the total loss incurred by UTHR in delaying their approval request is an unknown. The eight month time frame does not start until UTHR submits their request. Each and every week that UTHR delays in submitting their request, competitors gain an additional week to get their product(s) to market. I.M.H.O., we will see a significant increase in share price when UTHR makes the request to the FDA indicating they will be making use of MNKD to manufacture and provide the whistle to administer Tyvaso DPI. Please keep in mind, I have been wrong more times then not. L.O.L. Best of luck to all MNKD equity shareholders. Great summary👍🏻 |
|
|
|
Post by ronw77077 on Apr 12, 2021 14:22:28 GMT -5
Per the FDA's website:
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review).
|
|
|
|
Post by celo on Apr 12, 2021 15:01:51 GMT -5
Thanks winner for the elaboration. The 3.2 million/week was throwing me off, but I agree wholeheartedly with your summation.
|
|
