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Post by neil36 on May 23, 2022 17:41:33 GMT -5
The FDA denial letter to Scott Lassman is really something. Like someone else said, it’s like FDA sent a million daggers to Scott Lassman and ripped the petition to shreds. So happy to know FDA believes so strongly in our product and followed the science and held a high ethical and moral standard. I can’t believe I am going to say this, but FDA did amazing work today. It’s like the FDA asked Martine, MC and Mango to draft the response…..lol |
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Post by sayhey24 on May 23, 2022 17:55:43 GMT -5
After the FDA sends a notification of approval to UTHR. Did they send its yet? If they send today, probably before market open tomorrow. If they send on Thursday they would probably hold for market open on Tuesday. In part from the FDA reply on the CP: Docket No. FDA-2021-P-0714 2 I. BACKGROUND A. Tyvaso DPI Today, FDA approved NDA 214324 for Tyvaso DPI submitted by United Therapeutics Corporation (UTC) OK but what does that mean? In the old days they use to FAX the notification of approval. I would hope they are emailing these days. If that was done today we should see the PR before market open tomorrow. OR Did the FDA approve Tyvaso DPI at their "internal" meeting for submission into the approved drug database and the CP lawyers got ahead of themselves? The chinese chemist who worked for the FDA usually had about 3 days between the time the drug was entered in the database and the company's notification. This was the time frame Martin Shkerli used to send the email and stop the afrezza approval. I doubt that will happen in this case but Martin was released from prison the other day  |
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Post by ktim on May 23, 2022 20:28:28 GMT -5
As a long time mnkd bag holder, I’m not ready to pop open the. champagne but I’m very happy nonetheless. Great to hear that that there will be no boxed warning. I hope that this bodes well for the removal of Afrezza’s black box. Maybe not popping it open, but definitely seems time to have it chilling. Was beginning to question whether it would ever happen, but it appears the longstanding Mannkind FDA curse has been lifted. |
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Post by mango on May 23, 2022 20:33:34 GMT -5
In part from the FDA reply on the CP: Docket No. FDA-2021-P-0714 2 I. BACKGROUND A. Tyvaso DPI Today, FDA approved NDA 214324 for Tyvaso DPI submitted by United Therapeutics Corporation (UTC) OK but what does that mean? In the old days they use to FAX the notification of approval. I would hope they are emailing these days. If that was done today we should see the PR before market open tomorrow. OR Did the FDA approve Tyvaso DPI at their "internal" meeting for submission into the approved drug database and the CP lawyers got ahead of themselves? The chinese chemist who worked for the FDA usually had about 3 days between the time the drug was entered in the database and the company's notification. This was the time frame Martin Shkerli used to send the email and stop the afrezza approval. I doubt that will happen in this case but Martin was released from prison the other day Even Shkreli can’t stop what is coming.  www.tyvaso.com/dpi/ |
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Post by cretin11 on May 23, 2022 20:58:14 GMT -5
As a long time mnkd bag holder, I’m not ready to pop open the. champagne but I’m very happy nonetheless. Great to hear that that there will be no boxed warning. I hope that this bodes well for the removal of Afrezza’s black box. Maybe not popping it open, but definitely seems time to have it chilling. Was beginning to question whether it would ever happen, but it appears the longstanding Mannkind FDA curse has been lifted. Great to see you again ktim! Sure is nice having Martine helping us shed that curse, isn’t it? Agree let’s at least chill that champagne, we are closer to popping it. |
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Post by Deleted on May 24, 2022 0:34:51 GMT -5
OK but what does that mean? In the old days they use to FAX the notification of approval. I would hope they are emailing these days. If that was done today we should see the PR before market open tomorrow. OR Did the FDA approve Tyvaso DPI at their "internal" meeting for submission into the approved drug database and the CP lawyers got ahead of themselves? The chinese chemist who worked for the FDA usually had about 3 days between the time the drug was entered in the database and the company's notification. This was the time frame Martin Shkerli used to send the email and stop the afrezza approval. I doubt that will happen in this case but Martin was released from prison the other day  Even Shkreli can’t stop what is coming. www.tyvaso.com/dpi/Why can't MNKD have an instructional video like DPI?? That was great! |
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Post by Chris-C on May 24, 2022 1:02:05 GMT -5
I read the entire FDA response to the petition, point by point. They (LQDA probably) threw everything they could to challenge, delay or inhibit the marketability of Tyvaso DPI. Each of their assertions was carefully and effectively rejected by FDA. Additionally, the review shed light on the black box warning for Afrezza, which seems excessive given the safety data and careful analysis of 3 asthmatic patients who experienced bronchospasm. I'm pretty sure that additional data submitted by MNKD has satisfied FDA as to the safety of FDKP as an excipient. It's been 8 years since Afrezza was approved. Time to remove the black box. Lassman DID delay approval with their CP, which was designed to delay approval, so they came away with something for their anticompetitive effort. I think MNKD and UTHR should submit a CP For LQDA's next NDA.
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Post by sayhey24 on May 24, 2022 5:16:36 GMT -5
Chris - Will there be a "LQDA's NEXT NDA"? I expect Tyvaso DPI will burry this company.
I would hope the current afrezza black box is replaced and looks more like Tyvaso DPI's label in the future. My guess is BP had a hand in the CP because the last thing they want is one more barrier removed for afrezza use.
5.4 Bronchospasm
Like other inhaled prostaglandins, Tyvaso DPI may cause acute bronchospasm. Patients with asthma or
chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk
for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and
during treatment with Tyvaso DPI
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Post by mango on May 24, 2022 6:15:53 GMT -5
I read the entire FDA response to the petition, point by point. They (LQDA probably) threw everything they could to challenge, delay or inhibit the marketability of Tyvaso DPI. Each of their assertions was carefully and effectively rejected by FDA. Additionally, the review shed light on the black box warning for Afrezza, which seems excessive given the safety data and careful analysis of 3 asthmatic patients who experienced bronchospasm. I'm pretty sure that additional data submitted by MNKD has satisfied FDA as to the safety of FDKP as an excipient. It's been 8 years since Afrezza was approved. Time to remove the black box. Lassman DID delay approval with their CP, which was designed to delay approval, so they came away with something for their anticompetitive effort. I think MNKD and UTHR should submit a CP For LQDA's next NDA. I would hope MannKind and United would not stoop to the sleazy level Liquidia did with a disingenuous citizen petition. What a waste of time for FDA to have to go through it with a fine comb and reject each claim asserted by Scott Lassman et al. The anti competitive nature of citizen petitions as a whole needs major reform. |
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Post by uvula on May 24, 2022 7:02:44 GMT -5
Just forget record, we do not know who filed the CP.
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Post by peppy on May 24, 2022 7:27:00 GMT -5
Why can't MNKD have an instructional video like DPI?? That was great! MNKD has instructional videos for Afrezza. You didn't know there are instructional videos? There is a physician that explains everything well.dosing, when to dose, etc. I could not find the video. You tube has afrezza videos. |
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Post by jkendra on May 24, 2022 7:30:04 GMT -5
I wonder if mango's FOIA will be answered regarding the citizen's petition
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Post by mango on May 24, 2022 7:31:52 GMT -5
Just for the record, I emailed Scott Lassman last night to inform him of FDA’s denial and rejection of his citizen petition. Ironically, he has an automated reply set up stating he will be out of the office from May 23 through June 6.
Good time to take a vacation, eh?
😂
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Post by kite on May 24, 2022 8:04:18 GMT -5
Just for the record, I emailed Scott Lassman last night to inform him of FDA’s denial and rejection of his citizen petition. Ironically, he has an automated reply set up stating he will be out of the office from May 23 through June 6. Good time to take a vacation, eh? 😂 I'm sure he will have a full email inbox once he returns |
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