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Post by sweedee79 on Feb 24, 2022 14:45:56 GMT -5
A small part of me wants to be stoic. I want to say "C'est la vie." We'll get 'em next time." But at this moment, my inner child just wants to cry. Apparently, the world IS just as corrupt as I feared. May God help us all. My inner child is sobbing!!! So f#@+#king tired of this!!!! 😭 It never ends |
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Post by sayhey24 on Feb 24, 2022 14:56:00 GMT -5
If for some reason (hopefully for the better) Martine did initiate the amendment then she better throw MNKD a bone in some shape or fashion (buy-in, new molecule, etc.) as she should have fully known how this was going to impact MNKD's share price. What would Martine add to the NDA??? I am with Mango on this. I think Martine knew this was coming and was prepared and she was always looking at May as the time for Tyvaso launch. What I am thinking is UTHR responded with such detail to the technosphere safety question that the response caused it to be a major addendum. However, I have no idea how much safety data is really available for Tyvaso Technosphere. We know Tyvaso in the blood is safe and there is a lot of data there and we know Technosphere as an inert carrier is highly safe and there is a lot of data there but today's delay brings back Martin's Christmas email which said the new device needed to be tested even though we knew TS was TS regardless of whether a patient got it from the medtone device or the current inhaler. This request is a little different in that its a safety request and not a device requirement test. |
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Post by nylefty on Feb 24, 2022 15:07:30 GMT -5
Nate’s email was his usual take. In a nutshell: Surprised about the decision. FDA either corrupt or inept. Still believes in the company, and although frustrated, still believes Tyvaso DPI will be approved eventually, so not getting too worked up by the delay. Own/buy as much as you can and still comfortably sleep. He also said that if you've "had enough" there's nothing wrong with exiting your position entirely, although if you do sell he advises spreading out your sales "over a period of at least a few days." |
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Post by Chris-C on Feb 24, 2022 15:15:43 GMT -5
The FDA, because it is a large, awkward, bumbling bureaucracy that has to "appear to play fair" by its own rules, has to juggle too many competing demands within artificial timelines. Congress imposed the PDUFA legislation with good intentions but didn't allow for wildcards like government shutdowns, pandemics, and citizen petitions. Although I'm totally supportive of public input, I don't think the FDA should have to hold up its decisions as a result. That creates an avenue for exploitation by bad actors (as FDA itself has acknowledged). On the other hand, it conveniently gives the agency an excuse when they need one because they haven't completed their due diligence review in a timely manner. These petitions should be reviewed by a neutral panel with a high standard for determining whether a response is even warranted. Why should any application be obligated to respond to every CP that shows up, especially if it is hiding behind a veil of anonymity? I would think that UTHR, having seen this as a potential threat based on the CRL, would have already anticipated and prepared (in collaboration with MNKD) a comprehensive response as a contingency. Given Martine's upbeat assessment of the delay, I'd speculate that there is a better than an even chance that they have. I'm certain that MNKD is very tired of the FDKP safety argument.
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Post by lakers on Feb 24, 2022 15:24:50 GMT -5
2/24/22 MannKind said it has learned that the FDA considers a response by United Therapeutics to the agency's request for additional information to be a major amendment to the new drug application, which will extend the review deadline to May. The company, which is focused on inhaled therapeutic products for patients with endocrine and orphan lung diseases, said it was informed earlier this month that the FDA had requested additional information from United Therapeutics regarding the pulmonary safety of Tyvaso DPI related to a pending citizen petition, to which United Therapeutics promptly responded. Last October, MannKind said the FDA had declined to approve the application at that time for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The regulator at that time identified a deficiency related to an open inspection issue at a third-party analytical testing center for treprostinil, the active ingredient of Tyvaso DPI, though the FDA's response didn't pertain to MannKind, the company said. MannKind Corp.'s shares slid 20.4% to $2.92 Thursday after the company warned the deadline for the Food and Drug Administration to complete its review of the new drug application for a pulmonary arterial hypertension treatment being developed with United Therapeutics Corp. The stock has now fallen 33% so far this year, and more than 50% over the last 12 months. www.marketwatch.com/story/mannkind-shares-slump-20-after-delay-in-fda-review-of-tyvaso-dpi-271645719880United Therapeutics Earnings: Q4 FY21 sales increased 8% Y/Y to $415.2 million, missing the consensus of $427.62 million. Treprostinil-based product sales (Tyvaso, Remodulin, and Orenitram) grew by $23.5 million. The growth in Tyvaso revenues resulted primarily from an increase in quantities sold, reflecting the expansion of the Tyvaso label to include pulmonary hypertension associated with interstitial lung disease. Operating income increased from $65.3 million to $169.8 million, and net income improved from $98.8 million to $112.2 million. The company posted Q4 adjusted EPS of $3.51 missing the consensus of $3.72. Operating expenses declined to $245.4 million, down from $319.6 million on lower R&D and SG&A costs. Price Action: UTHR shares closed at $193.11, MNKD shares closed at $3.66 on Wednesday. |
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Post by hellodolly on Feb 24, 2022 15:30:15 GMT -5
1. Martine was ready because she likely had a copy in her hands months ago, made the preparations to hand over everything but the "kitchen sink" to bury the FDA with the data they are so anxious to have in order to approve the drug, and
2. There is enough data to satisfy the FDA in order to support a written response to the CP with facts, if they desire to do so...otherwise the FDA can wash their hands and tap out and file the CP in the circular bin.
As far as the statement by MNKD and UTHR last fall on the PR announcement for the delay....you do realize it can be both; one delay because of a third party facility and...hey, "...by the way we've had more time at the FDA to look into the CP and now we'd like to have more data on the pulmonary safety..."
My take is the FDA is a slow gigantic bureaucracy, like most (as I've been immersed in government work for 40 years)...one unit looked at the NDA and another looked at the CP thus, two different delays. I feel that May or earlier, is firmed up.
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Post by lakers on Feb 24, 2022 15:38:44 GMT -5
When a citizen petition works: FDA's review of United Therapeutics' PAH drug extended to May Nearly every time a biopharma company or its law firm files a citizen petition to delay a new or generic drug’s approval, the petition is shot down with a quick explanation from the FDA. Research from 2016 shows more than 90% of these petitions are ultimately rejected by the FDA, particularly as many are only filed with the intention of delaying an approval. But in limited cases, as with United Therapeutics and MannKind’s reformulated pulmonary arterial hypertension drug Tyvaso DPI, a citizen petition can actually work to push back the agency’s review timeline. Potential blockbuster Tyvaso, an inhaled version of treprostinil, hauled in a little more than $600 million in 2021, and is already approved to treat PAH and patients with pulmonary hypertension associated with interstitial lung disease. But last October, a dry powder formulation of treprostinil, known as Tyvaso DPI, was rejected by the FDA due to an open inspection issue at a contractor that performs analytical testing of the drug substance. At the time of the CRL, according to an investor note from SVB Leerink, United said that the latest draft labeling indicated that the Tyvaso DPI label would include both PAH and PH-ILD indications with no boxed warning and no contraindications. But now, the FDA says it’s taking a closer look at a July 2021 citizen petition concerning the safety of an excipient in Tyvaso DPI that’s also used in United partner MannKind’s inhaled insulin drug Afrezza. That petition — filed by DC-based lawyer Scott Lassman on behalf of an unidentified client — explains how Tyvaso’s dry powder formulation uses fumaryl diketopiperazine (FDKP), which is a novel excipient that “poses a serious risk of acute bronchospasm in patients with chronic lung disease, such as asthma and chronic obstructive pulmonary disease.” FDA reviewers have suggested that FDKP, which the petition describes as an irritant, is responsible — at least in part — for the acute bronchospasm observed in the Afrezza clinical trials. “As a result, Afrezza’s approved labeling carries a prominent ‘boxed warning’ alerting healthcare providers that Afrezza is contraindicated in patients with chronic lung disease and requires pre-treatment testing to identify potential lung disease in all patients,” the petition notes. Earlier this month, the FDA requested additional information concerning the pulmonary safety of Tyvaso DPI related to this pending citizen petition, the company announced Thursday. “We responded to the FDA’s request, and the FDA indicated that our response constitutes a major amendment to the Tyvaso DPI NDA, which extends the FDA’s anticipated deadline to review the pending NDA to May 2022,” United said in a statement. The FDA has yet to issue a final response on the citizen petition, but in an interim response from January, the FDA said the petition “raises complex issues requiring extensive review and analysis by Agency officials.” Launch preparation is already underway for Tyvaso DPI, according to a fireside chat with MannKind CEO Michael Castagna at the SVB Leerink Global Healthcare Conference last week, with sufficient supply for both PAH and PH-ILD indications. “Management noted they have prepared manufacturing and supplies for commercialization of Tyvaso DPI in both PAH and PH-ILD indications. The company expects ~80% conversion from nebulizer formulation to Tyvaso DPI,” Leerink added in a note. SVB Leerink said in another note published Thursday, “We would have expected that if the FDA viewed the issues raised in the CP [citizen petition] as warranting a boxed warning or contraindication, this would have been made apparent earlier in the review and evident in these draft labeling discussions. However, with the review ongoing, we would not rule out the possibility of the FDA contemplating final labeling that could include a boxed warning/contraindication.” endpts.com/when-a-citizen-petition-works-fdas-review-of-united-therapeutics-pah-drug-extended-to-may/ |
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Post by Clement on Feb 24, 2022 15:46:01 GMT -5
So, what would a "boxed warning/contraindication" mean to PAH and PH-ILD patients and their docs? I don't think it will matter a lot because of 1) UTHR dominance on that market and 2) the fact that a lot of the patients will be converting from nebulizer.
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Post by hellodolly on Feb 24, 2022 15:50:31 GMT -5
So, what would a "boxed warning/contraindication" mean to PAH and PH-ILD patients and their docs? I don't think it will matter a lot because of 1) UTHR dominance on that market and 2) the fact that a lot of the patients will be converting from nebulizer. Maybe I can get more help from the board but, likely a small percentage would not be able to use it, like Mike said in his fireside chat, due to the cough. Will doctors take a second look? Maybe...but UTHR isn't built like MNKD. They have a force multiplier of people who can assist. |
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Post by sayhey24 on Feb 24, 2022 16:27:05 GMT -5
So, what would a "boxed warning/contraindication" mean to PAH and PH-ILD patients and their docs? I don't think it will matter a lot because of 1) UTHR dominance on that market and 2) the fact that a lot of the patients will be converting from nebulizer. Probably nothing for Tyvaso DPI but the implications are much bigger because they relate back to afrezza and would help justify Mike's label change which he is preparing. Has there even been a reported case of TS causing ACUTE BRONCHOSPASM with afrezza over the last 7 years? Was there any reported case with Tyvaso DPI? IMO BP is going to do everything they can from allowing afrezza to be a more viable product. Removing the black box removes a big excuse why doctors should not prescribe. |
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Post by wyattdog on Feb 24, 2022 17:39:17 GMT -5
The first question during the uthr conference call was from Joe with a Owen and co. “ in terms of the safety protocol you’ve seen with tyvasa dpi to date some thoughts there especially as it relates to Bronchospasm.” Dr. Rothblatt: “ yeah thanks Joe. We’ve had some absolute great experiences with tyvaso dpi to date. We’ have not experienced those bronchospasms side effects that you referred to so we really don’t believe that is going to be an issue at all. I think it is all quite routine and it’s just the fda doing their job the best they can. As I mentioned in my introductory remark and as mike emphasized in his remarks 3 months is really meaningless in the context of this products life. This product has a very long tap life. It’s an amazing product. It’s so easy and convenient for patients to use. We have the great results of the Breeze trail. It’s going to end up being used,I’m confident by thousands and thousands. It’s just an amazing product. So it’ll get out there you know everyone just has to make sure that all the boxes are checked and the i’s are dotted and the t’s are crossed and as Mike said we feel confident with the launch by the timeframe set.”
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Post by wyattdog on Feb 24, 2022 17:40:01 GMT -5
Sorry that’s Cowen and co.
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Post by sportsrancho on Feb 24, 2022 17:45:58 GMT -5
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Post by cretin11 on Feb 24, 2022 18:00:11 GMT -5
Mike was speaking rather quickly today, but i think he said they had not been expecting today's FDA news and he was sorry about it, or words to that effect. I guess we'll see the transcript soon enough. But if Martine knew it was coming (and i'm not necessarily agreeing with mango that she did), wouldn't she have told Mike?
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Post by Clement on Feb 24, 2022 18:58:55 GMT -5
Vous avez les notes?
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