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Post by rob37 on Apr 4, 2014 4:23:41 GMT -5
pharmerboy87 • 4 hours ago
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Pharmacist's perspective on Afrezza prospects.
Hello everyone. I have been a MNKD long investor since 2011, but I don't post much on these boards. I have been a lurker for awhile. I watched the ADCOM through the FDA.live feed, and I helped Matese a little bit with his blog of it. I was really struck by the FDA panel's lack of understanding of this product and it's benefits.
I am a pharmacist, so I "speak the lingo" of the briefing documents and of most of the discussions on the ADCOM. I think the reason we did not hear more about the Post Prandial Glucose numbers is because FDA has a specific set of parameters that they have boxed themselves into using for diabetic approvals, and that is primarily HBA1C. So they don't care if the glucose swings wildly high and low, as long as the average (hba1c) looks good, then they are happy. That is why you saw all the patient testimonials talking about time in zone, hypos, hypers, etc. That is what is really important to diabetics, as I'm sure Afrezzauser can confirm. So while the FDA was freaking out about hba1c, bioavailability, efficacy, and the like, the panel saw right through it
Mannkind was basically forced to pound a square peg into a round hole to try to get afrezza approved, and when they couldn't get the data to be an overwhelming slam dunk, then FDA wanted to pick them apart for it. Luckily, they were able to show data that was good enough.
This is the part FDA doesn't get.. Afrezza is a drug that shifts the paradigm. Paradigm shifts are hard for people to see until after they are long shifted. Unfortunately, mannkind wasn't allowed to design a study that would have reflected this use under a new paradigm, thus the need to pound the square peg into the round hole. They have done it and will get approval. Once it is out there and being used, you will see that the experience of its use will result in it being used in ways that lead to superb control, never before possible. Afrezza wiill become first-line treatment for many diabetics.
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Post by spiro on Apr 4, 2014 7:42:15 GMT -5
And the word will spread like wildfire, as diabetics throughout the world learn of Afrezza through the internet, Fox news, OK maybe MSNBC too, family, friends, Superbowl ads and physicians. And then, just when we think things couldn't get any better, MNKD and partner launch the new technosphere cricket device for pain. This is why MNKD will be acquired much sooner than most of you think. BTW, I will allow them to call the new pain device, the " Spiro Cricket ", for a small royalty.
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Post by mdcenter61 on Apr 4, 2014 10:57:47 GMT -5
I second the nomination of the new product name "Spiro Cricket" and ask for further nominations to cease and to vote by acclimation!
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Post by 4allthemarbles on Apr 4, 2014 11:40:08 GMT -5
And the word will spread like wildfire, as diabetics throughout the world learn of Afrezza through the internet, Fox news, OK maybe MSNBC too, family, friends, Superbowl ads and physicians. And then, just when we think things couldn't get any better, MNKD and partner launch the new technosphere cricket device for pain. This is why MNKD will be acquired much sooner than most of you think. BTW, I will allow them to call the new pain device, the " Spiro Cricket ", for a small royalty. Spiro- you said the company would be acquired a lot soone than we think. Do you have a timeline in mind, if there is no delay of the 4/15 pdufa? I suppose this is a possibility, techno sphere has so much potential. If this does happen, does anyone have an idea what happens to the long term call options? |
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Post by milachka63 on Apr 4, 2014 12:43:50 GMT -5
And the word will spread like wildfire, as diabetics throughout the world learn of Afrezza through the internet, Fox news, OK maybe MSNBC too, family, friends, Superbowl ads and physicians. And then, just when we think things couldn't get any better, MNKD and partner launch the new technosphere cricket device for pain. This is why MNKD will be acquired much sooner than most of you think. BTW, I will allow them to call the new pain device, the " Spiro Cricket ", for a small royalty. Spiro- you said the company would be acquired a lot soone than we think. Do you have a timeline in mind, if there is no delay of the 4/15 pdufa? I suppose this is a possibility, techno sphere has so much potential. If this does happen, does anyone have an idea what happens to the long term call options? Re long term call options: as soon as there is a final bid and no more speculation about competing offers, the long term calls will lose all their time premium and will only have intrinsic value. I.e. takeover price - exercise price |
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Post by liane on Apr 4, 2014 12:46:46 GMT -5
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Post by 4allthemarbles on Apr 4, 2014 12:55:17 GMT -5
Thanks guys.
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Post by 4allthemarbles on Apr 4, 2014 12:57:08 GMT -5
So, even with some speculation, does anything think a buyout offer with come within 12 months of a pdufa?
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Post by nemzter on Apr 4, 2014 13:14:21 GMT -5
So, even with some speculation, does anything think a buyout offer with come within 12 months of a pdufa? Anything can happen in the next 12 months, partnership, buyout, bankruptcy ... choose your poison and invest wisely |
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Post by babaoriley on Apr 4, 2014 13:31:24 GMT -5
I would add to the options advice, that I believe the warrants, being securities issued by MannKind, would be treated differently (options are not issued by MNKD). I think there's some sort of formula used, so you don't necessarily lose all time value, but don't take that to the bank!
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