|
|
Post by sportsrancho on May 7, 2021 7:02:26 GMT -5
Thanks
|
|
|
|
Post by cretin11 on May 7, 2021 8:26:18 GMT -5
The FDA has two months from the date of submission to accept the NDA. So the FDA has until June 19 or so to accept the NDA.
The 6-months for an approval decision is marked from the date of acceptance. That is why the anticipated approval has been projected for December. If the FDA accepts the NDA much earlier, say, sometime in May, then approval would be expected in November. But don't count on that happening. Expect the FDA to accept the NDA close to June 19 and approval about the same time in December. That's just the way it is. And, yes, without other news the stock price will likely languish until we get closer to June 19, and then ditto for the time between acceptance and approval. Fortunately, there has to be other news before then. UTHR is doing the Tyvaso work, and we know MannKind isn’t pushing Afrezza aggressively now. So therefore they must be doing other things to add value, we should hear about that at the CC. |
|
|
|
Post by uvula on May 7, 2021 9:22:39 GMT -5
"UTHR is doing the Tyvaso work, and we know MannKind isn’t pushing Afrezza aggressively now. So therefore they must be doing other things to add value"
I wish I shared your optimistic outlook. Mnkd can't even file their paperwork on time.
|
|
|
|
Post by buyitonsale on May 7, 2021 14:34:36 GMT -5
The link below was already posted in this thread... www.fda.gov/media/78941/downloadIt is worth reviewing. We already know from UTHR that approval is expected in December. The only knowns are: official FDA acceptance and a confirmation that Priority Review Voucher will be used, as well as PDUFA date. Here are some important items from the FDA link: 2.4 Acknowledge Receipt of Submission The RPM sends a letter acknowledging the receipt of the application to the applicant by day 14. *** This should have already happened 3.1.3 Determine Preliminary Priority/Standard Review Schedule A tentative decision on priority designation should be made by day 14 to assist in scheduling the filing meeting (day 30 for a priority application or day 45 for a standard or Program-designated application). *** priority designation should have already happened *** 30 day filing meeting may happen after May 19, if priority designation has been decided on I think we may hear some news regarding FDA acceptance by end of May... |
|
|
|
Post by mnkdfann on May 11, 2021 13:41:55 GMT -5
Maybe this was posted elsewhere and I missed it, but in the latest UTHR earnings call they briefly discussed anticipated DPI uptake. seekingalpha.com/article/4424594-united-therapeutics-corporation-uthr-ceo-martine-rothblatt-on-q1-2021-results-earnings-call
[L]ook at DPI as really kind of fitting in. It's fitting kind of into that strategy of providing patient options. And so I would expect that with the DPI, you're going to have a significant number or majority of patients that are going to want to transition to the dry powder inhaler, and that's fantastic. You will have other patients that, for various reasons, may choose to stay on the nebulizer. And that's great.
We're going to continue to support that product. It's a great product. There is going to - I do think that there is going to be a patient type that is maybe better suited for that product over the DPI. Don't hold me to this. I think when the dust settles, you're probably looking at something of around a 70-30 split between dry powder and nebulizer. So we're going to continue to provide both options, support both options. And I think they're both great delivery devices for the right patient. |
|
|
|
Post by boca1girl on May 11, 2021 15:20:56 GMT -5
I remember earlier comments from UT saying that they would transition all of their customers to DPI and phase out the nebulizer. I don’t have a link but many here said that some will not transition, so DPI would not be 100%. I would bet that brand new patients will start on DPI and most of the current patients will switch over.
|
|
|
|
Post by derekewhitlock on May 11, 2021 15:45:48 GMT -5
All you have to do is look at the nebulizer v DPI equipment and the cleaning requirements of the Nebulizer and it is no-brainer. Notwithstanding the increased medical benefit of DPI. I would be shocked if over 5-10 % choose nebulizer over DPI once given choice...actually, I think that is high even.
|
|
|
|
Post by stevil on May 12, 2021 19:16:03 GMT -5
I wonder if it has to do with inspiratory pressure. One would think you'd have to inhale pretty deeply/have good air movement to get proper deep lung penetration with DPI. Maybe nebulizing is for those who are unable to breathe forcefully enough for the medication to get where it needs to go with a single breath.
|
|
|
|
Post by sellhighdrinklow on May 12, 2021 21:47:17 GMT -5
All you have to do is look at the nebulizer v DPI equipment and the cleaning requirements of the Nebulizer and it is no-brainer. Notwithstanding the increased medical benefit of DPI. I would be shocked if over 5-10 % choose nebulizer over DPI once given choice...actually, I think that is high even. If my memory is correct, 51 in study, 2 dropped 49 remained and 49 out of 49 chose the DPI over the nebulizer. Solid. |
|
|
|
Post by Clement on May 13, 2021 7:26:08 GMT -5
I wonder if it has to do with inspiratory pressure. One would think you'd have to inhale pretty deeply/have good air movement to get proper deep lung penetration with DPI. Maybe nebulizing is for those who are unable to breathe forcefully enough for the medication to get where it needs to go with a single breath. Great comment. From reading about design of the Dreamboat inhaler, we have learned that Mannkind had to design in some restriction to the airflow so that air would not move too fast through the inhaler. This leads me to think that, for Dreamboat, the delta P and velocity across the inhaler are not very important, but probably tidal volume and inspirational reserve volume are important for extremely compromised lungs. |
|
|
|
Post by longliner on May 20, 2021 11:01:09 GMT -5
Any indication what percent of MNKD shares United Therapeutics holds?
|
|
|
|
Post by boca1girl on May 20, 2021 11:10:15 GMT -5
Any indication what percent of MNKD shares United Therapeutics holds? Mike said UT holds shares in MNKD, nothing more. If they hold 5%, 10%, I think disclosures to SEC from UT, are required. |
|
|
|
Post by markado on May 20, 2021 14:09:49 GMT -5
Any indication what percent of MNKD shares United Therapeutics holds? Mike said UT holds shares in MNKD, nothing more. If they hold 5%, 10%, I think disclosures to SEC from UT, are required. Now, why would UTHR own shares of MNKD? That's not exactly diversification is it? The real question might be how many convertible shares they may have the opportunity to buy? |
|
|
|
Post by dh4mizzou on May 20, 2021 14:34:11 GMT -5
It could actually reduce the price they pay in an acquisition.
|
|
|
|
Post by markado on May 21, 2021 10:16:10 GMT -5
It could actually reduce the price they pay in an acquisition. Completely agree. My question was offered sarcastically. There are no guarantees, of course, but this segment is all about future option value and scalable plays. We shall see. My cards say hold'em and be all in. |
|
