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Post by itellthefuture777 on Oct 24, 2021 18:47:28 GMT -5
It’s a nit, but “own facility” and “in-house” are not exactly the same thing (although they likely are). I do not assume that UTHR was blind-sided (although maybe they were), nor do I assume that they are not willing to throw money at as rapid a solution as can be put in place. I’ve not studied how often 2nd CRLs happen but from this board and other places I’ve read I get the feeling they are not common meaning there’s a better than 50/50 chance (back to odds again) that UTHR will get things sorted out satisfactorily and hit close to the dates they’re saying. I also get the feeling that Dr. Rothblatt likes to set and achieve expectations and is too shrewd to be overly aggressive on setting expectations. All that to say I think the moves are more likely to be based on planning than scrambling. Second CRL in general or with respect to MNKD? lol With respect to MNKD 2nd CRLs statistically speaking are 100%. The FDA doesn't see things in the right perspective. Was instituted as a break on progress to insure safety and efficacy of drugs yet as we see they have now resorted to one open item issues of unrelated drug at a testing house 3rd party issue with a 4th party drug. It's an outrage to be held for approval. |
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Post by prcgorman2 on Oct 25, 2021 6:45:02 GMT -5
Thank you Captain Obvious? In case you missed it, we’re talking about the delay with the FDA approval of UTHR NDA, not MNKD.
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Post by prcgorman2 on Oct 26, 2021 6:51:53 GMT -5
Thank you Captain Obvious? In case you missed it, we’re talking about the delay with the FDA approval of UTHR NDA, not MNKD. Crap. This was meant for a post from ktim. |
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Post by porkini on Oct 26, 2021 8:22:54 GMT -5
Thank you Captain Obvious? In case you missed it, we’re talking about the delay with the FDA approval of UTHR NDA, not MNKD. Crap. This was meant for a post from ktim. The "Quote" button is your friend. Sincerely, Capt'n Obvious    |
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Post by longliner on Oct 26, 2021 10:13:54 GMT -5
Thank you Captain Obvious? In case you missed it, we’re talking about the delay with the FDA approval of UTHR NDA, not MNKD. Crap. This was meant for a post from ktim. Everyone here knew who it was for. Even those that didn't like the message.............. |
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Post by sportsrancho on Oct 26, 2021 14:10:50 GMT -5
Crap. This was meant for a post from ktim. The "Quote" button is your friend. Sincerely, Capt'n Obvious I do this a lot🤣 …you think you can get away with less steps. Lol I love less steps …… same reason women love permanent make up. And that’s why if I was a diabetic I would be on Afrezza immediately! Not to mention it’s aesthetically appealing. I have what they call a buddy pack that’s magnetic that you put on your waist when you jog or run that can hold your cell phone and keys…there is also enough room in there for an inhaler. You can pack it to go anywhere. |
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Post by mytakeonit on Oct 26, 2021 14:28:38 GMT -5
That's why I have 4 bathrooms in my house.
But, that's mytakeonit
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Deleted Member
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Post by Deleted on Oct 26, 2021 18:36:09 GMT -5
That's why I have 4 bathrooms in my house. But, that's mytakeonit WELL...................aren't you Special..... |
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Post by ktim on Oct 26, 2021 22:00:43 GMT -5
Thank you Captain Obvious? In case you missed it, we’re talking about the delay with the FDA approval of UTHR NDA, not MNKD. Crap. This was meant for a post from ktim. I suppose that was an obvious joke. Seemed teed up. Anyone could have taken the swing, lol |
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FDA delay
Oct 28, 2021 10:18:27 GMT -5
via mobile
Post by cretin11 on Oct 28, 2021 10:18:27 GMT -5
Crap. This was meant for a post from ktim. I suppose that was an obvious joke. Seemed teed up. Anyone could have taken the swing, lol You gotta make it more obvious for certain folks 😂 |
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Post by prcgorman2 on Oct 28, 2021 15:00:33 GMT -5
I suppose that was an obvious joke. Seemed teed up. Anyone could have taken the swing, lol You gotta make it more obvious for certain folks 😂 I assume you mean potential investors. |
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