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Post by 4Balance on Sept 4, 2014 2:33:49 GMT -5
The other board highlighted this new article in USA TODAY. 11 companies fighting for survival"Some companies themselves declare they may not be able to continue being a going concern. Medical developer MannKind issued unaudited financial statements that went into detail on why the company’s longevity could be threatened. The company’s most promising product is Afrezza, an inhalable insulin the company says was approved by the U.S. Food and Drug Administration on June 27 for the treatment of diabetes. However, the company frankly states in its financials it has net losses of $2.4 billion and cash and cash equivalents as of June 30 of $41.2 million. The company points out its survival hinges on raising additional money either by selling debt or stock, striking business deals or cutting costs. Until the company tops these hurdles “there will be continued substantial doubt about our ability to continue as a going concern,” the company said in its filing. And lately investors have focused on the negatives:" (chart follows) americasmarkets.usatoday.com/2014/09/03/11-companies-fighting-for-survival/....and a little over a month after the financials are filed, MNKD cuts a "business deal" with SNY. Derek mentioned that MNKD has been making these statements for years. If so, and subsequently did what it said it needed to do, it seems like no clear reason for concern. Why didn't the review take that into consideration? Do we think that article is the primary reason for today's PPS weakness..?? MNKD and many other biotechs are routinely going concerns. That is part of being a startup biotech... That the article picked MNKD as part of that list as opposed to any other biotexh with a MK above 300 million is possibly because MNKD has the larger MK then mot biotechs. Is the list/ information still valid after the deal with Sanofi? No but I doubt the writer of the article cares. Then again the aim of the article could have been to bring down the price of MNKD and or DryShips (the other company they mentiovery to me every piece of financial information is ad priori not neutral. Some would say that is being a tad paranoid but then again when dealing with markets every angle is or wil be used for the aim of making money. It would be good timing after EXEL's news yesterday. How many people reas this stuff? It obviously seems to get around. Is it causing today's price move? I certainly don't know. JPG On face value it strikes me as careless reporting (at best) or an attempt to suppress the PPS (at worst). --4B
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Post by biotec on Sept 6, 2014 8:43:04 GMT -5
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Post by thekindaguyiyam on Sept 6, 2014 11:03:55 GMT -5
Biotech did you find anything he said dishonest or misleading?
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Post by 4Balance on Sept 6, 2014 12:48:20 GMT -5
I evidently missed the FDA approval of the Cricket device. We received the 2nd CRL due to a change to Dreamboat...so I know the device matters.
Was the Cricket used in most recent trials, and thus covered by the FDA approval...??
-4B
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Post by brentie on Sept 6, 2014 12:59:24 GMT -5
I evidently missed the FDA approval of the Cricket device. We received the 2nd CRL due to a change to Dreamboat...so I know the device matters. Was the Cricket used in most recent trials, and thus covered by the FDA approval...?? -4B No, I don't think Cricket was ever used with Afrezza because taking insulin is not a one time deal. The second CRL was because all the trials were done with the Medtone Inhaler and MNKD tried to switch to Dreamboat without proving bioequivalence( to the FDA's satisfaction) between the two inhalers.
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Post by biotec on Sept 6, 2014 14:23:21 GMT -5
Biotech did you find anything he said dishonest or misleading? Afrezza asides, MannKind now focuses on the expansion of the company's proprietary Technosphere platform to catapult what will be unseen growth in the history of the biopharmaceuticals industry Is MNKD working on expansion?
Resourceful and strategic firms, besides Sanofi, are already seeking co-development efforts with MannKind to tap into the Technosphere's Matrix and enjoy tremendous growth and competitive advantages for decades, if not centuries, to come
First I heard of this!
The ramifications and applications for Technosphere cover a vast number of therapeutic areas not limited to pain, migraine, anti-anti-nausea, anti-obesity, osteoporosis, GI disorder, pulmonary arterial hypertension, vaccination, respiratory disorder, and adjuvant therapies. MannKind and certain partners already filed and received patent approvals for various conditions not only in the US, but also in key markets that are enormous and expanding like Mainland China.
Certain partners ket markets like mainland China. Who are these partners?
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Post by liane on Sept 6, 2014 14:29:29 GMT -5
These days I've got nothing but time on my hands as I fractured my Fibula 8/15 on the first day of my vacation in Lake Havasu This is no fun!! Bet you could use some ultra rapid acting inhaled pain medication!
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Post by Deleted on Sept 6, 2014 14:31:14 GMT -5
I evidently missed the FDA approval of the Cricket device. We received the 2nd CRL due to a change to Dreamboat...so I know the device matters. Was the Cricket used in most recent trials, and thus covered by the FDA approval...?? -4B No, I don't think Cricket was ever used with Afrezza because taking insulin is not a one time deal. The second CRL was because all the trials were done with the Medtone Inhaler and MNKD tried to switch to Dreamboat without proving bioequivalence( to the FDA's satisfaction) between the two inhalers. Isn't the tech identical once Dreamboat is loaded? That is to say The "inards" are the same between a loaded Dreamboat and a pre-loaded(packaged) Cricket. I'd guess a Cricket/Afrezza combo may not need any additional FDA approval.
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Post by hansmolo on Sept 6, 2014 17:35:42 GMT -5
Any drug delivered via the cricket device will require an FDA approval of the device/drug combo. Matt P explained to me yesterday that the cricket device doesn't require an FDA review on its own, but any drug that will be delivered via the device will be reviewed as a drug/device combo. Exactly how when the FDA approved Afrezza, they approved the delivery of Afrezza via the dreamboat.
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Post by biotec on Sept 6, 2014 17:47:45 GMT -5
Any drug delivered via the cricket device will require an FDA approval of the device/drug combo. Matt P explained to me yesterday that the cricket device doesn't require an FDA review on its own, but any drug that will be delivered via the device will be reviewed as a drug/device combo. Exactly how when the FDA approved Afrezza, they approved the delivery of Afrezza via the dreamboat. Years away and a lot of money that MNKD dont have. If MNKD wants to further the pipeline it will be all on Afrezza success or more stock dilution.
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Post by 4Balance on Sept 6, 2014 18:16:16 GMT -5
Any drug delivered via the cricket device will require an FDA approval of the device/drug combo. Matt P explained to me yesterday that the cricket device doesn't require an FDA review on its own, but any drug that will be delivered via the device will be reviewed as a drug/device combo. Exactly how when the FDA approved Afrezza, they approved the delivery of Afrezza via the dreamboat. That makes sense to me. With the 2nd CRL the FDA required a bioequivalency study of Medtone and Dreamboat. Now I suspect they'd require a bioequivalency study for Dreamboat and Cricket. I wonder if Sanofi and/or MNKD intends to do that...it would be a good question to ask...unless single-use Afrezza applications are not part of the plan since the Cricket is being marketed for treatment of NONchronic diseases. --4B
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Post by seanismorris on Sept 9, 2014 0:54:15 GMT -5
SEPTEMBER 04, 2014 CDC: Every state has an obesity problem The Centers for Disease Control and Prevention's latest obesity news indicates an overall widening of the US. The health agency's latest data indicates that 20% was the lowest level of obesity prevalence in any state in the US among adults. The findings also showed a regional narrative: southern states had the highest rates, with 30.2% of adults ranking as obese, just outrunning the Midwest, which had a 30.1% rate, the Northeast, which hovered at 26.5% and the West, in which 24.9% of adults were obese. The numbers matter because they represent a long list of potential health issues, including diabetes, cancer and heart disease. An August CDC report indicated that the US diabetes risk has jumped to 40%. This one condition is associated with $245 billion in related healthcare costs, and patients have to put up more money for these medications, which can put adherence at risk. Article has a link to an older article Quote from that one: In addition to the undiagnosed, the CDC also notes that around 37% of US adults qualify as pre-diabetic. This means around 86 million adults could tip into the diabetes category, diagnosed or otherwise.
www.mmm-online.com/cdc-every-state-has-an-obesity-problem/article/369808/
It sounds like we'll pass the point were over 50% of the adult population in the US is either diabetic or pre-diabetic very soon...
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Post by brentie on Sept 9, 2014 8:48:44 GMT -5
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Post by bradleysbest on Sept 9, 2014 9:21:23 GMT -5
The guy is wrong ! PPS went down after FDA approval & partnership! Bozo....
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Post by brentie on Sept 9, 2014 10:28:25 GMT -5
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