|
|
Post by boca1girl on Dec 27, 2021 8:54:55 GMT -5
|
|
|
|
Post by cjm18 on Dec 27, 2021 10:02:18 GMT -5
3rd party test house cleaned up or UTHR moved on to a new one? Question for those that have the background...If they moved forward with a new contractor, would they've had to perform tests on the product to show they're standards are superior and up-to-date before UTHR refiled the NDA or can UTHR find an FDA pre-approved facility that has recently been inspected and meets testing proficiency levels? Think that is the big question. Probably the difference between a class 1(2 months) and class 2(6 months) response. Note the fda documentation states "A resubmission that requires a reinspection also would be a Class 2 resubmission". So I definitely hope it is an already inspected testing facility. Guess we will know in 30 days when they Issue an acknowledgement letter. At least the clock starts at the receipt of the resubmission. What are the chances of a second complete response letter? Hoping for the best, but preparing for the worst. The acknowledgment letter will specify class 1 or 2? |
|
|
|
Post by hellodolly on Dec 27, 2021 12:56:05 GMT -5
I renamed this thread given the optimism of today's news. Good move, I woke up this a.m. and saw the 8K posted on my phone pop up alerts. Came here first and the top thread was the old CRL title...I about died. I finally realized the topic date was 10/91/2021...whew. New MNKD crisis averted for now. |
|
|
|
Post by liane on Dec 27, 2021 13:00:28 GMT -5
I had the same problem
|
|
|
|
Post by Clement on Dec 28, 2021 11:09:38 GMT -5
Maybe there will be an acceptance letter within 30 days? Acceptance here means FDA accepts the resubmission of the NDA for consideration. There is no approval at the time of the acceptance letter.
Then after some amount of time, would there be a new PDUFA date? By summer?
|
|
|
|
Post by akemp3000 on Dec 28, 2021 11:31:02 GMT -5
I don't think there's a hard and fast rule for how the FDA acts on this. Quite often they've issued a response weeks and even months before a PDUFA date. I don't see another PDUFA date being announced just to address the 3rd party testing site issue. I'm expecting a ruling sometime between one and four months. If UTHR moved the testing to a FDA site currently being inspected and approved, it's possible the FDA could respond with an early acceptance. If not, the expectation remains that it will be "before summer". I like the idea that no one, especially shorts, knows when the FDA will act. Any clarifications for the FDA process following this past letter would be appreciated.
|
|
|
|
Post by peppy on Dec 28, 2021 12:07:46 GMT -5
I have a non helpful comment to make regarding FDA inspected and approved site.
Reading about the COVID vaccines. Where did I see this?
The FDA had only inspected and approved 5 sites where the vaccines are made.
The thought ran through..... is the FDA site inspection situation backed up secondary to the demand placed on it with COVID19?
Non helpful, over and out.
|
|
|
|
Post by prcgorman2 on Dec 30, 2021 7:34:57 GMT -5
Given the interval between the CRL and the filing of the NDA, I assume “next steps” had to be completed prior to the NDA filing. The good news is, whatever those “next steps” were, they are now complete and we move to the next phase prior to approval.
I don’t assume new approval headwinds materialized. Regardless, I took the “before summer” estimate with a grain of salt. The exact timing in 2022 is less important than the result.
|
|
|
|
Post by nxc2 on Dec 31, 2021 2:23:40 GMT -5
My guess is approval June 27, 2022. 6 months from resubmission. My assumption is priority review still applies and thus 6 months. Also early summer as Martine stated.
|
|
|
|
Post by boca1girl on Dec 31, 2021 10:09:57 GMT -5
My guess is approval June 27, 2022. 6 months from resubmission. My assumption is priority review still applies and thus 6 months. Also early summer as Martine stated. I will counter with a two month review and approval in March. |
|
|
|
Post by nxc2 on Jan 1, 2022 8:49:34 GMT -5
My guess is approval June 27, 2022. 6 months from resubmission. My assumption is priority review still applies and thus 6 months. Also early summer as Martine stated. I will counter with a two month review and approval in March. I hope you are right! |
|
|
|
Post by boca1girl on Jan 3, 2022 8:19:20 GMT -5
Maybe we will learn more on Thursday at the JP Morgan conference. Register to listen live at UTHR website.
Upcoming Events
Listen to webcast
January 6, 2022 8:00 AM ET
Fireside Chat with Martine Rothblatt and Michael Benkowitz
|
|
|
|
Post by neil36 on Jan 6, 2022 7:56:37 GMT -5
www.regulations.gov/document/FDA-2021-P-0714-0007 Scott M. Lassman Lassman Law + Policy 1717 K Street, N.W., Suite 900 Washington, DC 20006 Re: Docket No. FDA-2021-P-0714 Dear Mr. Lassman: I am writing to inform you that the Food and Drug Administration (FDA) has not yet resolved the issues raised in your citizen petition received on July 8, 2021. Your petition requests that the Agency refuse to approve the new drug application for Tyvaso DPI (treprostinil) inhalation powder unless certain criteria are met. FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials. This interim response is provided in accordance with FDA regulations on citizen petitions (21 CFR 10.30(e)(2)). We will respond to your petition as soon as we have reached a decision on your request. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 w ww.fda.gov Sincerely, Carol Bennett Digitally signed by Carol -S Bennett -S Date: 2021.12.29 11:18:01 -05'00' Carol J. Bennett Deputy Director Office of Regulatory Policy Center for Drug Evaluation and Research
|
|
|
|
Post by boca1girl on Jan 6, 2022 8:57:49 GMT -5
Maybe we will learn more on Thursday at the JP Morgan conference. Register to listen live at UTHR website. Upcoming Events Listen to webcast January 6, 2022 8:00 AM ET Fireside Chat with Martine Rothblatt and Michael Benkowitz Listened to the presentation this morning. Martine spent time talking about T-DPI and the progress made towards FDA approval. The 3rd party inspection process was moved to another location in record time at 69 days. They have not gotten a response from the FDA as of yet, so she could not give any other specifics related to Class I or Class II review. She expects a high conversion to T-DPI but not 100% because current patients are reluctant to switch therapies. She does expect 100% of new diagnosed patients to use the DPI version. She also spent time talking about supply chain concerns but emphasized that all of their products are made in the USA and they have stock piles of inventory. So I suspect that MNKD is producing lots of product for UTHR. The lawsuit with LQDA was brought up but didn’t say much let allow the layers to litigate the case. |
|
|
|
Post by Clement on Jan 6, 2022 9:18:47 GMT -5
Maybe we will learn more on Thursday at the JP Morgan conference. Register to listen live at UTHR website. Upcoming Events Listen to webcast January 6, 2022 8:00 AM ET Fireside Chat with Martine Rothblatt and Michael Benkowitz Listened to the presentation this morning. Martine spent time talking about T-DPI and the progress made towards FDA approval. The 3rd party inspection process was moved to another location in record time at 69 days. They have not gotten a response from the FDA as of yet, so she could not give any other specifics related to Class I or Class II review. She expects a high conversion to T-DPI but not 100% because current patients are reluctant to switch therapies. She does expect 100% of new diagnosed patients to use the DPI version. She also spent time talking about supply chain concerns but emphasized that all of their products are made in the USA and they have stock piles of inventory. So I suspect that MNKD is producing lots of product for UTHR. The lawsuit with LQDA was brought up but didn’t say much let allow the layers to litigate the case. Re: resubmission of Tyvaso DPI to FDA ----- Martine said she expects to find out within one month whether class 1 or class 2. She also said she doesn't know if inspection will be required. |
|
