As usual we shareholders are out in the cold guessing about something Faupel could have told us in 10 seconds on the last CC.
Forget about figuring it out. No one on this board ever will.
This is just one more instance of Faupel telling us half the story and believing apparently that we are all too dense to wonder why or what the rest of the facts are.
Yahoo! Finance doesn't let you post links to SEC filings. Brilliant, eh?
Go to the Guided Therapeutics website, investors page, regulatory filings, and read the one dated 2013-05-20.
Yup. Waiting for my million-dollar lottery ticket to pay off.
I cleverly sold TTNP after it broke 2.00, and am I glad I did.
This is the original study on which all of Guided's filings, submissions, and marketing are based. The PR announces that the study, years after having been completed, is being published in a prestigious medical journal.
Big money rotates in and out sectors.
Wait for the bottom and buy more.
They'll be back.
Adam, is this the study you were referencing that was published in the Diabetes, Obesity and Metabolism journal? Volume 14, Issue 2, pages 163–173, February 2012.
Pulmonary function over 2 years in diabetic patients treated with prandial inhaled Technosphere Insulin or usual antidiabetes treatment: a randomized trial
Aims: Development of inhaled insulin has increased the need to understand its pulmonary safety. This study evaluated pulmonary function changes in diabetes patients receiving inhaled Technosphere Insulin (TI) or usual antidiabetes treatment (usual care).
Methods: This randomized, open-label study was conducted at 220 sites (25 July 2005 to 29 August 2008). Pulmonary function tests [forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), total lung capacity (TLC) and lung diffusion capacity for carbon monoxide (DLCO)] were prospectively followed over 2 years in patients with type 1 or type 2 diabetes receiving TI (n = 730) or usual care (n = 824), along with a cohort without diabetes not receiving any specific therapy (n = 145).
Results: Baseline demographics and pulmonary function were similar between diabetes treatment groups. Lung function declined from baseline in all groups. TI was non-inferior to usual care for mean change in FEV1 from baseline to month 24 [mean (s.e.m.) 0.037 (0.0119) l; 95% CI 0.014 to 0.060] using mixed-model repeated-measure with a pre-specified non-inferiority margin of 50 ml/year. After a greater initial decline at month 3 with TI, rate of change (slope) in FEV1, FVC and DLCO (months 3–24) was not statistically different between treatment groups. TI was well tolerated; no serious safety concerns emerged. The most common respiratory event associated with TI was mild, transient cough, occurring within minutes of inhalation.
Conclusions: Observed changes in lung function with TI were small, occurred early after therapy initiation, remained non-progressive over 2 years and were unlikely to be clinical
Sentiment: Strong Buy
No. This is not a threat. In fact., Lily is a prime candidate to partner with or buy out Mannkind.
Once-a-week dulaglutide, if approved, would be complementary to -- not competitive with -- Afrezza, if approved. In trials that compared dulaglutide to insulin, it was a basal insulin that was being compared, not a prandial insulin like Afrezza. In fact, in one of the trials (AWARD-4) dulaglutide was used with lispro, a fast-acting prandial insulin.
From a NY Times article on gold's plunge:
"Hedge funds have used gold E.T.F.’s to gain exposure to the precious metal, but have been selling them off en masse in recent weeks. The largest such exchange-traded fund, with the ticker symbol GLD, had its most active day ever on Monday. "
Hedgies will short anything to lift money out of anybody's pockets.
Raiding gold makes all the sense in the world, as gold bugs' paranoia about fiat money inflated gold way beyond reason. Hedgies noticed and attacked.
A recent SA article that I think was posted on this board explained that hedgies operate like a pack of hyenas when they hit their prey . . . because one hedgie can't crash a pps alone. They have to work together to muster the money necessary to manipulate a pps successfully.
It's hard to admit to yourself when something you are holding is overbought, especially because everyone starts believing pps is going to 10 or 20 dollars with no bear raid between here and there. You can see when a bear raid is a possibility, but you can never know for sure that one is imminent, so it's hard to know for sure you are at a top and the bears are going to hand you a major pullback if you sell.
Swimming with sharks. It would be so cool to KNOW when they are going to strike. Then you can sell, buy back, and pocket the difference.
Of course, buy and hold for the long term is a solid strategy with a good stock, but your courage will be tested.
One nit bothers me, which is that , because CE Mark depends on continued ISO certification, when Guided eventually scales production out of its in-house facility, whoever they contract manufacturing to is going to have to qualify for ISO certification on an ongoing basis.
This is probably a non-issue, but I have more confidence in Guided doing their own work hands-on than trusting their future to a third party.
Also, I still maintain that Guided will be enormously successful in ROW with or without FDA approval, particularly in underserved markets where it will almost certainly be used for primary screening.
Sentiment: Strong Buy
If you have enough cash to survive until to the finish line, you will almost certainly make a million dollars on this stock. :-)
Sentiment: Strong Buy
Feuerstein says: "If you're wondering why the MannKind's stock price is going up, it's largely due to short seller buy-ins caused by a big spike in the cost of borrowing shares." He goes on to conclude: "In other words, this is not a demand-driven move."
Bottom line is Feurstein, Wilson -- Shrek, the whole lot of them -- are shorting MNKD, and since they are being left in the dust and have no scruples as long as they are making money, they are engineering a transparently ridiculous bear raid to steal shares from weak holders who don't understand the value of what they're holding
But warrant holders selling short to lock in profit are an entirely different phenomenon than hedgies raiding a stock to plunder, loot, and pillage.
Locking in profit is not intended to hammer pps to buy back later as a bear raid is because: a) the warrants are in hand, and b) supporting pps is in the warrant holder's interest.
Warrants are exercised judiciously to provide supply when buyers' enthusiasm wanes. Providing a discount to some encourages bystanders to get in, too.
I would much rather see warrants exercised than an FUD-driven bear raid. I also feel that warrant holders deserve to take profit because they were willing to put up serious money to acquire them.
The news reports that pummeled Titan yesterday assume that people implanted with the rod will magically stop using opiods, if not immediately then in a month or two.
That isn't what probuphine is designed to do.
Probuphine is designed to -- and does -- provide a maintenance dosage of buprenorphine, with safety and compliance benefits, that enables an addict to abstain from opiods without experiencing withdrawal.
Abstinence is as much a behavioral question as a pharmacological one.
Given that probuphine suppresses withdrawal symptoms for an addict who abstains, s/he is able then to work with his or her behavioral issues until s/he ultimately abstains from opiods altogether.
When a person has a broken leg, you give that person a crutch so they can walk around until the bone heals. Probuphine is a crutch. It helps addicts stay away from opiods by suppressing withdrawal symptoms if they do.
Go to MannKind's home page.
Click on "News and Events."
Click on "MannKind at Cowen Health Care Conference," which just happened to occur on March 5, 2013.
This is why the stock is running.
Funds that dumped MNKD on FDA rejection realize Afreeza will be approved this time and are buying it back.
Sentiment: Strong Buy
The funds that dumped MNKD on the last FDA non-approval are buying MNKD back because this time Afrezza will be approved, marketed, and a blockbuster drug. Of course this is My opinion only. Idiot.
Instead of waiting for a pullback, spend half your powder now.
You can buy more on a pullback later wherever and whenever it comes.
Watching a monster breakout and wishing for a pullback is silly.
Buy now. If a pullback does come, buy more when it bottoms, at a pps that could be higher or lower than what it is now.
Sentiment: Strong Buy
Just like GTHP changed LuViva models after they submitted their PMA.
Look at MNKD today. They are repeating their Phase 3 trials with their changed inhaler, and the whole world knows Afreeza will be approved . . . and be a multi-billion dollar game changing drug.
Don't give up on GTHP. Be patient.