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Post by harryx1 on May 23, 2022 13:09:38 GMT -5
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Post by sayhey24 on May 23, 2022 13:13:37 GMT -5
Maybe afrezza will get similar wording and the black box will get removed- lets hope.
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 avi8torslc on May 23, 2022 13:14:30 GMT -5
Pretty clean
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Post by cretin11 on May 23, 2022 13:19:41 GMT -5
Martine is a rock star!
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Post by mango on May 23, 2022 13:26:28 GMT -5
Hell yeah!!!!
What a fantastic day.
MannKind Longs FINALLY got a miraculous victory!
Congratulations ya’ll. Whew…
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Post by anderson on May 23, 2022 13:32:55 GMT -5
So how long before Mannkind is not labeled as a `speculative` biotech company, but just a biotech company.....or did that just happen?
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Post by mango on May 23, 2022 13:40:11 GMT -5
Well since both the label and the CP response are officially published by FDA, when will we get a PR from United and MannKind?
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Post by hellodolly on May 23, 2022 13:53:17 GMT -5
Nice 15 page reply by FDA to Lassman Law.
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Post by sayhey24 on May 23, 2022 13:53:37 GMT -5
Well since both the label and the CP response are officially published by FDA, when will we get a PR from United and MannKind? 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. |
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Post by mango on May 23, 2022 14:07:59 GMT -5
Well since both the label and the CP response are officially published by FDA, when will we get a PR from United and MannKind? 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) |
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Post by cretin11 on May 23, 2022 15:40:55 GMT -5
Hell yeah!!!! What a fantastic day. MannKind Longs FINALLY got a miraculous victory! Congratulations ya’ll. Whew… Nothing miraculous about it. Totally expected and the correct decision, just a few months later than it should've been. This is what we should come to expect! TS is legit as we have known for many many years. |
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Post by Deleted on May 23, 2022 16:07:38 GMT -5
download report here. www.regulations.gov/document/FDA-2021-P-0714-0008Conclusion: the FDA agency does not believe additional pre-market safety data were required to support the approval of NDA 214324 for Tyvaso DPI. Any potential pulmonary risks of Tyvaso DPI are adequately characterized by the available date and appropriately addressed and mitigated through product labeling. Further, we do not believe a contraindiciation, boxed warning, or REMS should be included in product labeling. Consequently, the Petition is denied. MUSIC TO MY EARS!!!!! |
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Post by celo on May 23, 2022 16:55:44 GMT -5
Nice! Fantastic work by United and Mannkind!
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Post by mango on May 23, 2022 17:38:23 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.
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Post by Deleted on May 23, 2022 17:41:30 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. I wont be impressed until they REMOVE the Black Box Warning on Afrezza. They have deemed FDKP as SAFE so it's time to remove the Albatross!! |
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