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Post by mnkdfann on Sept 29, 2017 15:27:50 GMT -5
If I understand correctly, the meeting was scheduled for today. But is there any confirmation that it took place as scheduled?
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Post by dreamboatcruise on Sept 29, 2017 15:38:59 GMT -5
If I understand correctly, the meeting was scheduled for today. But is there any confirmation that it took place as scheduled? I've actually never heard anyone state it as a "meeting". Mike did say it is the PDUFA date. Whether that entails a meeting, or simply having the last of a step of sign-offs occur is perhaps something someone with experience with the process could chime in on. Being PDUFA simply means they they are supposed to notify MNKD of the decision by today. I do wish MNKD management had set expectations properly. It may be that announcing a label change really wouldn't be expected on the actual PDUFA date... but lack of clarity on this by management has allowed the market to expect news today. Still could be... but I wonder if that is really the way it normally plays out. |
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Post by ilovekauai on Sept 29, 2017 15:42:52 GMT -5
FIASP being approved today, whilst we sit does not make me happy. FDA/BP collusion against Afrezza is always a possibility. Fingers crossed that we get really good news on Monday. I was hoping for that good news today. Disappointed that did not happen, but no the first time with this investment. We've been through so much and will continue to endure towards a great conclusion. Regardless of all the attacks MNKD has dealt with, the winning hand is ours in the end. Onwards!
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Post by centralcoastinvestor on Sept 29, 2017 15:45:22 GMT -5
If I understand correctly, the meeting was scheduled for today. But is there any confirmation that it took place as scheduled? I've actually never heard anyone state it as a "meeting". Mike did say it is the PDUFA date. Whether that entails a meeting, or simply having the last of a step of sign-offs occur is perhaps something someone with experience with the process could chime in on. Being PDUFA simply means they they are supposed to notify MNKD of the decision by today. I do wish MNKD management had set expectations properly. It may be that announcing a label change really wouldn't be expected on the actual PDUFA date... but lack of clarity on this by management has allowed the market to expect news today. Still could be... but I wonder if that is really the way it normally plays out. Mike C. definetly stated he expected notification today or over the weekend. So, we hear about it Monday. Hopefully.  I sure hope the FDA does right by us this time. |
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Post by dreamboatcruise on Sept 29, 2017 15:54:39 GMT -5
I've actually never heard anyone state it as a "meeting". Mike did say it is the PDUFA date. Whether that entails a meeting, or simply having the last of a step of sign-offs occur is perhaps something someone with experience with the process could chime in on. Being PDUFA simply means they they are supposed to notify MNKD of the decision by today. I do wish MNKD management had set expectations properly. It may be that announcing a label change really wouldn't be expected on the actual PDUFA date... but lack of clarity on this by management has allowed the market to expect news today. Still could be... but I wonder if that is really the way it normally plays out. Mike C. definetly stated he expected notification today or over the weekend. So, we hear about it Monday. Hopefully. I sure hope the FDA does right by us this time. So it seems your expectation is that MNKD will make an announcement as soon as they receive the PDUFA notification from FDA without any additional steps. Hopefully that happens, as I suspect most people do have that expectation because of lack of any other guidance. If I were Mike, I think I might have given a little wriggle room by saying the announcement might be delayed a bit beyond the official PDUFA... that's just me. |
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Post by sportsrancho on Sept 29, 2017 17:07:54 GMT -5
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Post by sportsrancho on Sept 29, 2017 17:13:14 GMT -5
They will hear, ( I'm thinking tomorrow ) just like was said. And PR it early Monday. It's news to me that anyone thought it would be today?
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Post by babaoriley on Sept 29, 2017 17:18:32 GMT -5
They will hear, ( I'm thinking tomorrow ) just like was said. And PR it early Monday. It's news to me that anyone thought it would be today? |
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Post by babaoriley on Sept 29, 2017 17:19:56 GMT -5
Do not want news today or tomorrow. Those are bad news times. Monday morning is fine!
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Post by broncolife on Sept 29, 2017 17:27:47 GMT -5
Mike dropped the breadcrumbs we just failed to follow them. I was guilty of it also.
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Post by nylefty on Sept 29, 2017 17:39:52 GMT -5
It's a PR maxim that you release bad news late on Friday afternoon or Saturday (when most people aren't paying attention). I'm looking forward to good news on Monday.
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Post by LosingMyBullishness on Sept 29, 2017 18:48:41 GMT -5
NVO down a penny from $48.and change. AFREZZA down five pennies TO $2.17. There will be no news today, or Monday other than no label change. My guess is we are under $2.00 on Monday. What exactly are you predicting? The PDUFA is today. Are you predicting that all of the options for label change will be denied? That we won't hear about it for awhile simply because even after PDUFA there could still be details to be worked out about label change? That FDA will request MNKD agree to an extension of PDUFA date? Even if FDA makes the decision today based on PDUFA deadline, I don't think that guarantees we hear about it by Monday, so you may be right on that. But I'm assuming you're predicting FDA outright rejects label changes, correct? I fear that you read too much in that post. |
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Post by sportsrancho on Sept 29, 2017 18:52:07 GMT -5
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I sure hope the FDA does right by us this time.
