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Post by sportsrancho on Oct 17, 2021 3:05:54 GMT -5
That's all I got, plus 3 buy orders under 5  Looking forward to next week! Thank you buy❣️Buy buy buy💪🏻 |
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Post by BD on Oct 17, 2021 7:15:07 GMT -5
I think this thread is misnamed and as such, misleading. It has NOT been established that there is a delay in FDA approval. Neither company identified October 15 as a specific date for approval; (nor did the FDA); the companies only stated that the decision was expected in October, 2021. Thus, by any measure, it is not accurate to speculate on a delay until November 1. I adjusted the subject line. |
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Post by Clement on Oct 17, 2021 10:15:54 GMT -5
Check out what happened on one occasion previously. Look for United Therapeutics on March 31 on this list. Then go to United Therapeutics press releases and find the corresponding release at 6:00am the next morning. This doesn't necessarily mean we get approval tomorrow --- just maybe. |
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Post by sportsrancho on Oct 18, 2021 5:05:25 GMT -5
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Post by hellodolly on Oct 18, 2021 5:13:00 GMT -5
Draft label contains both PAH and PH-ILD indications; no contraindications and no boxed warning
Complete response cites an open inspection issue at a third-party analytical testing facility; no other deficiencies cited
Approval and launch expected in summer 2022 or earlier.
In addition, the FDA did not cite any deficiencies or issues related to operations performed at the MannKind Corporation facility for manufacture, testing, and packaging of finished Tyvaso DPI, including its associated device. All other requests from the agency have been addressed.
Makes me wonder what the open inspection issue at the third party facility actually is...some testing documents not signed off properly...or something more lame? Apparently something UTHR feels can be resolved quickly and back into the hands of the FDA for approval by summer or EARLIER.
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Post by liane on Oct 18, 2021 5:16:59 GMT -5
Well doesn't that just suck! A deficiency out of left field.
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Post by hellodolly on Oct 18, 2021 5:19:41 GMT -5
Well doesn't that just suck! A deficiency out of left field. No less, a third party. Happy to see MNKD has it all squared away. |
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FDA delay
Oct 18, 2021 5:23:43 GMT -5
via mobile
Post by sportsrancho on Oct 18, 2021 5:23:43 GMT -5
“On Friday, October 15, 2021, the FDA issued a complete response declining to approve the NDA at this time. The FDA's letter noted only a single deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance.”
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Post by lakon on Oct 18, 2021 5:25:39 GMT -5
Looks like a cop out, and I do not like the ominous last statement about "the FDA has not yet completed its review of a Citizen’s Petition...", thus leaving open wiggle room for more nonsense. Yet, be sure to take your vax, and here's some new meds for Alzheimer's. ARGH!
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Post by hellodolly on Oct 18, 2021 5:34:30 GMT -5
Tells me this is going to be approved by summer or earlier. I'm glad that little caveat "or earlier" was added. Will keep some traders off guard as the approval could come out of left field in the Spring, IMHO. |
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Post by liane on Oct 18, 2021 5:40:51 GMT -5
And no hit on the UTHR sp as yet!
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Post by sweedee79 on Oct 18, 2021 5:44:14 GMT -5
Looks like a cop out, and I do not like the ominous last statement about "the FDA has not yet completed its review of a Citizen’s Petition...", thus leaving open wiggle room for more nonsense. Yet, be sure to take your vax, and here's some new meds for Alzheimer's. ARGH!
Exactly!!! That citizens petition... Just what lqda needed and wanted!!! |
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Post by cretin11 on Oct 18, 2021 5:48:02 GMT -5
And no hit on the UTHR sp as yet! That is strange, but it has to hit them. Maybe not as big of a hit as for us, because they have such a stronger foundation to absorb the impact. |
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Post by akemp3000 on Oct 18, 2021 6:01:58 GMT -5
Well that was $105M wasted unless this gets reversed quickly. The worst part is all the PAH patients having to wait to improve their lives.
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Post by goyocafe on Oct 18, 2021 6:02:53 GMT -5
At least Nate can start pounding his “Strong buy under 5” again.
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