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Post by boca1girl on May 5, 2021 10:35:17 GMT -5
If MNKD provides a full year revenue forecast next week, I hope they clearly state their expectations for FDA T-DPI approval in December as an assumption for their projections.
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Post by akemp3000 on May 5, 2021 11:29:16 GMT -5
Wondering when MNKD will begin large scale manufacturing considering FDA approval is expected in December. Considering UTHR paid the $105M to expedite, I'm guessing manufacturing and the payment to MNKD for such will begin in 4Q prior to approval so UTHR can immediately begin advertising and hit the street running. The risk to start manufacturing a little early should be considerably less costly than what they paid to expedite the approval process. If so, MNKD could see manufacturing revenue during 4Q and royalties immediately thereafter. A good time is coming.
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Post by sportsrancho on May 5, 2021 12:03:33 GMT -5
There should be no if, it’s absolutely essential to provide guidance.
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Post by nylefty on May 5, 2021 12:10:10 GMT -5
Wondering when MNKD will begin large scale manufacturing considering FDA approval is expected in December. Considering UTHR paid the $105M to expedite, I'm guessing manufacturing and the payment to MNKD for such will begin in 4Q prior to approval so UTHR can immediately begin advertising and hit the street running. The risk to start manufacturing a little early should be considerably less costly than what they paid to expedite the approval process. If so, MNKD could see manufacturing revenue during 4Q and royalties immediately thereafter. A good time is coming. MannKind has been posting a lot of manufacturing jobs recently so it looks like those hired will be trained and put to work well before December. |
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Post by cedafuntennis on May 5, 2021 13:46:21 GMT -5
I think that would be a bit premature. Guidance may come next quarter once the approval is in place. I would not issue guidance, especially after not having any for a few years past, until I have the approval in hand. FDA is a finicky group and corruption was not a stranger to that group in the past as we all know.
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Post by mytakeonit on May 5, 2021 14:21:10 GMT -5
If you say so ... BUT, have you bought your 1M cheap shares yet? Time is running out ...
But, that's mytakeonit
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Post by boca1girl on May 5, 2021 16:56:53 GMT -5
I think that would be a bit premature. Guidance may come next quarter once the approval is in place. I would not issue guidance, especially after not having any for a few years past, until I have the approval in hand. FDA is a finicky group and corruption was not a stranger to that group in the past as we all know. MNKD has not had a good track record with guidance and that’s why they stopped a while ago. However, most companies do and MNKD will be expected to in order to gain WS confidence. I’m not anticipating guidance at this earnings call but the need to be prepared for 2022. |
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Post by longliner on May 5, 2021 18:02:19 GMT -5
I think that would be a bit premature. Guidance may come next quarter once the approval is in place. I would not issue guidance, especially after not having any for a few years past, until I have the approval in hand. FDA is a finicky group and corruption was not a stranger to that group in the past as we all know. MNKD has not had a good track record with guidance and that’s why they stopped a while ago. However, most companies do and MNKD will be expected to in order to gain WS confidence. I’m not anticipating guidance at this earnings call but the need to be prepared for 2022. They certainly can issue guidance regarding anticipated Tyvaso DPI manufacturing royalties they expect to receive prior to approval in December. |
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Post by sportsrancho on May 6, 2021 16:52:17 GMT -5
When are we going to get that submission so we know when the date for the FDA approval is? ....that’s why the stock is bleeding in my opinion. Plus the low volume stuff.
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Post by boca1girl on May 6, 2021 18:20:26 GMT -5
When are we going to get that submission so we know when the date for the FDA approval is? ....that’s why the stock is bleeding in my opinion. Plus the low volume stuff.  They already submitted: United Therapeutics Announces Submission of Tyvaso DPI™ New Drug Application to FDA NDA submission includes both pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease indications Priority review voucher applied to the NDA submission SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., April 19, 2021 |
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Post by sportsrancho on May 6, 2021 18:23:37 GMT -5
When are we going to get that submission so we know when the date for the FDA approval is? ....that’s why the stock is bleeding in my opinion. Plus the low volume stuff. They already submitted: United Therapeutics Announces Submission of Tyvaso DPI™ New Drug Application to FDA NDA submission includes both pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease indications Priority review voucher applied to the NDA submission SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., April 19, 2021 But they haven’t got excepted. |
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Post by dh4mizzou on May 6, 2021 18:48:27 GMT -5
ACCEPTED!!
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Post by sportsrancho on May 6, 2021 18:59:37 GMT -5
Accepted... sorry was talking into the microphone. |
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Post by dh4mizzou on May 7, 2021 6:23:17 GMT -5
Understand totally.
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Post by oldfishtowner on May 7, 2021 6:58:17 GMT -5
The FDA has two months from the date of submission to accept the NDA. So the FDA has until June 19 or so to accept the NDA.
The 6-months for an approval decision is marked from the date of acceptance. That is why the anticipated approval has been projected for December. If the FDA accepts the NDA much earlier, say, sometime in May, then approval would be expected in November. But don't count on that happening. Expect the FDA to accept the NDA close to June 19 and approval about the same time in December. That's just the way it is.
And, yes, without other news the stock price will likely languish until we get closer to June 19, and then ditto for the time between acceptance and approval.
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They already submitted: