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Post by awesomo on Feb 23, 2022 13:37:22 GMT -5
The counter scenario would be they are ramming through their earnings call before the decision, make of it what you will.
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Post by cretin11 on Feb 23, 2022 13:37:47 GMT -5
I would think Tyvaso is already baked into the current MNKD pps but I hope I am wrong. On Geisinger, they had a dedicated diabetes clinic. Pottsville was identified as being a T2 hot spot a few years back. Afrezza could have really helped them. The last I heard they were trying to get people to eat more carrots. I am not sure the clinic is still open. I really doubt an income stream of $100 mill annually going directly to the bottom line is baked into the SP at this point. Sure it will take a couple of years for the $100 mil to materialize but starting a provable path to it will make wonders to MNKD with only about 250 mil shares outstanding or so. That’s a fair perspective. What is your vote in the poll? |
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Post by cretin11 on Feb 23, 2022 13:39:39 GMT -5
The counter scenario would be they are ramming through their earnings call before the decision, make of it what you will. That would be such weak sauce (but can’t deny the thought crossed my mind), I could imagine MC doing that but not Martine. Let’s hope that is not what’s going on, I like akemp’s scenario better. |
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Post by awesomo on Feb 23, 2022 13:41:28 GMT -5
The counter scenario would be they are ramming through their earnings call before the decision, make of it what you will. That would be such weak sauce (but can’t deny the thought crossed my mind), I could imagine MC doing that but not Martine. Let’s hope that is not what’s going on, I like akemp’s scenario better. True, though the likely scenario is that we are all completely clueless, like akemp says. |
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bkdmd
Researcher
Posts: 79
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Post by bkdmd on Feb 23, 2022 14:03:16 GMT -5
After all of these years....and years, my thought is here we go again.
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Post by mnkdfann on Feb 23, 2022 14:34:31 GMT -5
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Post by sayhey24 on Feb 23, 2022 15:47:26 GMT -5
I would think Tyvaso is already baked into the current MNKD pps but I hope I am wrong. On Geisinger, they had a dedicated diabetes clinic. Pottsville was identified as being a T2 hot spot a few years back. Afrezza could have really helped them. The last I heard they were trying to get people to eat more carrots. I am not sure the clinic is still open. I really doubt an income stream of $100 mill annually going directly to the bottom line is baked into the SP at this point. Just do your own calculations and let's not be like those low information people who take all what MSBNC or CNN or other bartenders tell them as gospel without processing. Sure it will take a couple of years for the $100 mil to materialize but starting a provable path to it will make wonders to MNKD with only about 250 mil shares outstanding or so. Let me better say this - Tyvaso approval is already baked into the pps. I agree the $100M is not baked in but what is, is this is MNKD. Does the street believe $100M in revenue is coming MNKD's way? If something can go wrong with MNKD it will has been the rule. When that changes the pps will too but near term I am not expecting much. I hope I am wrong but here I am watching "Inventing Anna" and who pops on the TV but Martin Shkreli. I just sit here and think of all the potential MNKD has and the pps is at $3.68 right now. I guess we have another buying opportunity and I sure wish these opportunities would end. |
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Post by mytakeonit on Feb 23, 2022 15:58:20 GMT -5
Yep ... and when it takes off ... you'll think "Oh, I should have bought more shares!"
But, that's mytakeonit
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Post by cppoly on Feb 23, 2022 16:16:25 GMT -5
What time does the FDA close? Is there still a possibility for an announcement today?
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Post by prcgorman2 on Feb 23, 2022 17:14:19 GMT -5
News releases for this will be coordinated between UTHR and MNKD, but I don’t know how FDA fits into it. Approval could have been done today, but no announcement until tomorrow.
If January 18th acknowledgement of FDA acceptance of UTHR NDA for Tyvaso DPI started the PDUFA regulatory clock for a Type 1 response, the FDA would have until mid-March.
UTHR will update us pre-market open and I give us a less than 50/50 chance of approval having happened today. Not saying a non-approval, but just that AFAIK, the FDA never published the date they were marching to.
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Post by sayhey24 on Feb 23, 2022 19:15:56 GMT -5
Yep ... and when it takes off ... you'll think "Oh, I should have bought more shares!" But, that's mytakeonit When this takes off I should be in pretty good shape. Maybe I would even open a few VDex like clinics to pay it forward. Of course I look at today and think another 20k cheap shares would be a good idea. 20k shares at $100pps would almost buy another beach house. For $100pps to happen - "something has to change" on how the street views MNKD and how MNKD executes. Tyvaso should be a good first step. |
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Post by mytakeonit on Feb 24, 2022 4:32:49 GMT -5
Say Hey 2 beach houses 4 you is totally wrong. People already are calling you a son of a beach ! Can you handle more sunburn  But, that's mytakeonit |
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Post by chauffe00 on Feb 24, 2022 6:51:54 GMT -5
News releases for this will be coordinated between UTHR and MNKD, but I don’t know how FDA fits into it. Approval could have been done today, but no announcement until tomorrow. If January 18th acknowledgement of FDA acceptance of UTHR NDA for Tyvaso DPI started the PDUFA regulatory clock for a Type 1 response, the FDA would have until mid-March. UTHR will update us pre-market open and I give us a less than 50/50 chance of approval having happened today. Not saying a non-approval, but just that AFAIK, the FDA never published the date they were marching to. That must explain today’s news |
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Post by chauffe00 on Feb 24, 2022 6:54:05 GMT -5
Say Hey 2 beach houses 4 you is totally wrong. People already are calling you a son of a beach ! Can you handle more sunburn But, that's mytakeonit Stop being so beachy 😜 |
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Post by lennymnkd on Feb 24, 2022 6:58:43 GMT -5
MannKind has now learned that the FDA considers the response to be a major amendment to the NDA, thereby extending to May 2022 the FDA’s deadline to complete its review of the pending NDA.
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