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Post by mango on Aug 24, 2017 3:32:07 GMT -5
oh, haha, I get it, #make afrezza globally available, #maga map afrezza profitable, #map good one you all. Make America Glucose Aware. |
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Post by bioexec25 on Aug 24, 2017 5:27:26 GMT -5
Make Amgen Get Afrezza :-)
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Post by mikesmilitaria on Aug 29, 2017 13:04:11 GMT -5
They will talk about the new office furniture for the Westlake Village HQ (that they purchased on sale for 50% off) and reiterate that international deals are still pending.
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Post by sportsrancho on Aug 29, 2017 13:07:40 GMT -5
I'm really sorry. I assumed wrong:-( Because of the shareholder conference Matt had. I thought Mike meant he was holding two in Sept.
Nate has just said that is not right. They are going to be presenting at two conferences this month. And has confirmed that with MNKD.
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Post by dreamboatcruise on Aug 29, 2017 13:14:57 GMT -5
Well, that explains fixing the time period. Though obviously now not having any implied meaning we might have hoped for... e.g. announcing some deal that they were far enough along to have a conclusion date.
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Post by mike0475 on Aug 29, 2017 16:06:14 GMT -5
Two meetings... still hopeful based on 2 meetings the label change is sooner than later now
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Post by dreamboatcruise on Aug 29, 2017 16:32:46 GMT -5
Two meetings... still hopeful based on 2 meetings the label change is sooner than later now There is a deadline for the label change decision from FDA of Sept. So we either get the change or a rejection by then. And management has said there were multiple variants submitted, so highly likely something is approved (IMO). |
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Post by babaoriley on Aug 29, 2017 16:54:25 GMT -5
What date in September, if you know, dbc?
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Post by dreamboatcruise on Aug 29, 2017 18:49:24 GMT -5
What date in September, if you know, dbc? My memory isn't what it used to be, but I don't actually recall a specific date ever being given. A quick Google turned up the following from the call Matt did in Mar. I don't know offhand how many months are allowed for the approval. If it is 6 months, then it would seem the date would be no later than Sept 13 since Matt referenced having a PDUFA in this call on Mar 13. Perhaps someone else remembers more. I'm guessing that the transcript has an error and that the label change might have to do with what they "call" Afrezza rather than how they "haul" it... though would be funny to describe it as an ultra-rapid insulin hauled by cart and donkeys. |
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Post by mnholdem on Aug 29, 2017 19:42:38 GMT -5
Would that be what baba would call an "ass"-inine statement?  |
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Post by peppy on Aug 29, 2017 19:49:18 GMT -5
many months ago, when Ray first mentioned the paperwork had been done and submitted for new label, ray said, august.
in the conference call now days he is saying sept.
translation = any day now.
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Post by saxcmann on Aug 29, 2017 20:03:59 GMT -5
Sept 30
just a guess.
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Post by compound26 on Aug 29, 2017 20:58:47 GMT -5
many months ago, when Ray first mentioned the paperwork had been done and submitted for new label, ray said, august. in the conference call now days he is saying sept. translation = any day now. September 30, 2017 has been confirmed as the PDUFA date by the management a couple times now. So we can just use that date as the assumed date. |
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Post by factspls88 on Aug 29, 2017 21:42:13 GMT -5
many months ago, when Ray first mentioned the paperwork had been done and submitted for new label, ray said, august. in the conference call now days he is saying sept. translation = any day now. September 30, 2017 has been confirmed as the PDUFA date by the management a couple times now. So we can just use that date as the assumed date. Yup - Though I am holding out hope that it will be earlier since the data is pretty straitghtforward. |
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Post by therealisaching on Sept 9, 2017 18:29:34 GMT -5
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