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Post by spiro on Dec 9, 2013 17:54:26 GMT -5
MannKind (NASDAQ: MNKD ) is hoping for a big year in 2014. The company's entire future pretty much hinges on the approval of its inhaled insulin product Afrezza and its delivery apparatus dubbed 'Dreamboat' next year. To recap, Mannkind reported positive late-stage trial data for its Afrezza/Dreamboat combo this year, and subsequently filed a NDA with the FDA. An approval could come as early as next April. Why is MannKind worth watching? The diabetes market is ridiculously big and is expected to grow to a mind-boggling $100 billion by 2018. It's so big that both Eli Lilly and Novo Nordisk's fast-acting insulin products have reached megablockbuster status, and sales are still growing. What's important to keep in mind, however, is that the Afrezza/Dreamboat combo is actually superior to these products in terms of delivering insulin. Specifically, Afrezza is an ultra-fast acting insulin that reaches peak levels within 14 minutes. As such, it is much better at mimicking the natural function of the pancreas than the fast-acting insulin analogues that take up to 30 minutes. In a nutshell, Afrezza/Dreamboat may be the product of choice, if approved, because it is inhalable and provides faster peak insulin levels. Even though MannKind does have a high market cap for a developmental stage biotech, this is definitely a company to watch in the New Year. www.fool.com/investing/general/2013/12/09/dynavax-mannkind-and-orexigen-could-have-a-big-yea.aspx |
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Post by ashiwi on Dec 9, 2013 18:25:28 GMT -5
Nice to hear something so positive coming from MF For a change. Could it be that the shorts are finally about to throw in the towel and start to cover? New short interest for Nov 30 is released at 4:00 Tuesday Dec 10. Should be interesting to see what Adam Feuerstein has to say in his next piece.
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Post by biotec on Dec 9, 2013 19:16:55 GMT -5
Its been so nice not hearing from Adam Feuerstien.Its been awhile
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Post by spiro on Dec 9, 2013 19:54:56 GMT -5
A.F. will be back soon. He is probably working on developing another desperate attack on Afrezza and MNKD. Ok, let me guess what his next attack will say. He will say that it has not disclosed that Afrezza may cause lung cancer, strokes, high blood pressure, heart attacks, broken bones, jock itch, athlete's foot and measles. Not excluding rabies, ringworm, ticks and fleas. I have already ordered a flea collar.
Of course, this is JMHO,
Spiro
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Post by savzak on Dec 9, 2013 22:45:52 GMT -5
I saw that article earlier today. It seems as though the positive press is heating up a bit. Mysteriously, it seems to be coinciding with an increase in daily volume and upward pressure on the price per share. Let's hope it all continues.
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Post by Chris on Dec 10, 2013 0:41:17 GMT -5
I saw that article earlier today. It seems as though the positive press is heating up a bit. Mysteriously, it seems to be coinciding with an increase in daily volume and upward pressure on the price per share. Let's hope it all continues. Great observation, let's see how MNKD fairs tomorrow and the day-after. The overall market was up today and a series of positive articles were all published today. The gain in PPS could be a false move with large blocks passing at a price under the bid figure, followed by smaller transactions at prices running up above the offered price. Vigilantly watch as a move to bid up the stock may be done in order to sell another large block. Dec. 28 however is a near term catalyst (74-day) letter. An immediate announcement by MNKD MGMT stating no panel is required may cause the stock to surge (despite it being near January, which is still far from from April's decision date). A end of the year tax loss sell off combined with a "new year" Q1 surge may lift MNKD a bit early as it trades sideways until another break occurs come March/April. All speculation of course. |
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Post by babaoriley on Dec 10, 2013 1:08:11 GMT -5
Hopefully making an early run, like it did early this year starting, when, February? Never thought it would move as early as it did in anticipation of the two phase III results, and the move was accompanied with a positive media blitz, which I'm confident all remember. AF will surely be around soon enough, though.
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Post by biotec on Dec 10, 2013 9:33:51 GMT -5
Its nice seeing the positive articles. I don't believe the (74-day) letter will have to much effect on the stock price. I do think we are going to start seeing a run up to Aprils FDA decision.Like bab said the run up started in late February for the trial results, Thats a six month window. Also well hear something about a partner. Shorts are going to have to cover. I think we are sitting very good at this time. Wild days ahead.
All speculation.
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Post by Chris on Dec 10, 2013 11:27:45 GMT -5
Its nice seeing the positive articles. I don't believe the (74-day) letter will have to much effect on the stock price. I do think we are going to start seeing a run up to Aprils FDA decision.Like bab said the run up started in late February for the trial results, Thats a six month window. Also well hear something about a partner. Shorts are going to have to cover. I think we are sitting very good at this time. Wild days ahead. All speculation. I'll ask you this, If the FDA requests a panel will the share price not be effected as a shift in sentiment may occur? This is the reason why I believe it may lift the share price up even if only temporarily. We'll see soon enough, what will happen with MNKD.  |
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Post by babaoriley on Dec 10, 2013 14:16:42 GMT -5
A panel would be bad news for the share price, if for no other reason, it gives the AF's of the world a free shot!
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Post by Chris on Dec 10, 2013 15:12:17 GMT -5
A panel would be bad news for the share price, if for no other reason, it gives the AF's of the world a free shot! Agreed, no panel will consequently have an adverse effect IMO as it reduces uncertainty and increases optimism. News stating no panel is necessary may increase the share price temporarily by 3-7 percent just as Al Mann's interview on TV caused a brief up-tick surge. Baba, have you seen TNXP? Every time Springer mentions a stock, it surges! A well calculated and positioned article near a possible breakout for MNKD + Springer article would be something to look for in the future. |
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Post by rak5555 on Dec 10, 2013 15:14:53 GMT -5
I suspect that the 74 day letter will either request an advisory panel or it will be silent as regards a panel, thus leaving the FDA's option (and our speculation) open. However, it should be noted that over the past several years, there is no material difference in approval rates between NDA's with or without advisory panels.
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