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Post by nylefty on Sept 29, 2017 12:46:17 GMT -5
The fact that FIASP has been approved and news released today is clearly an indication that there will be no label change in AFREZZA. Big pharma has Mannkind right where the want it...been a rock and the FDA! Clearly? As in "clear as mud?" By the way, NVO is actually down a little after the news. |
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Post by itellthefuture777 on Sept 29, 2017 12:47:41 GMT -5
Afrezza has "instant" onset of action..I'd say that's pretty damned ultra rapid Well, that's half good enough... do you also head the FDA  I wish! |
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Post by dreamboatcruise on Sept 29, 2017 12:53:36 GMT -5
The fact that FIASP has been approved and news released today is clearly an indication that there will be no label change in AFREZZA. Big pharma has Mannkind right where the want it...been a rock and the FDA! NO label change? I think that is unlikely. I wouldn't venture to bet on whether we get "ultra" but I think we will have a label change. |
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Post by lennymnkd on Sept 29, 2017 13:45:52 GMT -5
This is as much about BIG technology as it is about BIG pharma !
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Post by orlon on Sept 29, 2017 14:07:07 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.
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Post by thekid2499 on Sept 29, 2017 14:11:43 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. Your comments are getting a bit repetitive and tiresome. We get it. You don't think there will be a label change. Enjoy your weekend! |
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Post by peppy on Sept 29, 2017 14:12:50 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.I'll take that for a down side. What is the up side? Let's say, an ultra-fast label? What do you see as an upside?
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Post by dreamboatcruise on Sept 29, 2017 14:19:36 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? |
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Post by op2778 on Sept 29, 2017 14:25:56 GMT -5
Orlon has the crystall ball.....LOL
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Post by LongMNKD on Sept 29, 2017 14:36:26 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.I'll take that for a down side. What is the up side? Let's say, an ultra-fast label? What do you see as an upside?
I agree. Very good risk to reward. Down side loose 40 cents pps... Up side. Gain 2.00 pps? More? Squeeze? |
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Post by orlon on Sept 29, 2017 14:49:08 GMT -5
The only thing that is going to drive MNKD is sales.....if the label change is ultra fast hopefully it will drive up sales. Remember, it still has a black box warning...doctors are skittish over lung cancer etc. Convince the docs...no crystal ball, just a little common sense and a look at history.
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Post by kc on Sept 29, 2017 14:49:31 GMT -5
I don't care when the announcement is made. Better it be a surprise to the market vs an expectation. The date and time is no matter to this long.
Gomer Pile once said.
SURPRISE, SURPRISE SURPRISE.
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Post by kc on Sept 29, 2017 14:50:51 GMT -5
The only thing that is going to drive MNKD is sales.....if the label change is ultra fast hopefully it will drive up sales. Remember, it still has a black box warning...doctors are skittish over lung cancer etc. Convince the docs...no crystal ball, just a little common sense and a look at history. ORLON perhaps you didn't know that every drug has a black box warning. We need to get over that issue. Not a big deal. I don't hear about it causing death. |
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Post by orlon on Sept 29, 2017 14:55:39 GMT -5
You don't have to convince me. You need convince the doctors.
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Post by peppy on Sept 29, 2017 15:09:54 GMT -5
You don't have to convince me. You need convince the doctors. We have to convince insurance. once doctors can write the script and carry on, their patients will be happier. this is insurance. subq rapid acting insulin are close to chit as far as I can tell. this whole thing is a money game.
a gal testing fiasp on a website saying it stings through her pump.
The FDA has been approving meds (fiasp) and monitors (libre) in the past few days. Afrezza data is pretty easy to see.
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