I am split, but I see either way as it will get interesting first of the year...either a Ad Comm, which could seal a partnership if positive committee vote, or if there is no Adcom, I think its very likely that an early approval will come down the pipe.
34 out of the 35 drugs (97%) met the target
dates agreed to under the Prescription Drug
User Fee Act (PDUFA),
2012 FDA Approval Statistics
- FDA Website
My bosses Mortimer and Randolph Duke would say that sounds like a good idea, and also think about shorting the oranges because we got the crop report right here :)
He has tweeted that he has no interest in MNKD, and even wished them luck a while back. Said he was too busy with his Retrophin company or whatever they are calling it. If your looking for a good short, thats a good place to start.
LOL! If your like the King, your broke because you went all in on BIOD, and now work at Burger King cleaning toilets.
Oh its going bye bye on the inevitable partnership deal that will happen in Dec or January at the latest. Mark this post. Its going back to $7+ at a minimum.
Any statement from the FDA, i.e. Likelihood of approval or moving up approval date, will price in the approval and $14 easy.
All of this adds up to a epic short squeeze that will have shorties jumping out of windows.
The real scam was BIOD, and you fell for it sucker!
Question for you: Burger King or Taco Bell - who has cleaner toilets?
Yeah your right the FDA does always release their own opinions before ADCOM stating likelihood of approval. Happens every time lol.
Everyone who thinks a drug MUST be approved before BP's will partner up is in for a nasty surprise, possibly as early as next Monday if Sierra rumors are correct.
Today the FDA basically jumped the gun by 2.5 months and said Vanda's sleep disorder drug warrants approval, sending shares up 70%!!!!
They did this 2 days before the Advisory Committee was to meet to make a recommendation to the FDA!!! On top of that the PDUFA date isn't until January 31, 2014!!!!!
Imagine if the FDA made a similar statement Afrezza in January!!!!
George Rho's Deleted Comment:
"I don't like critiquing fellow SA contributors but it's really difficult to take your work seriously. You continually pump ORMP, a microcap with a minuscule market capitalization of $55 million and about $1 million in cash, while never missing an opportunity to bash MNKD, which is a far more substantial company, one founded and headed by a man who has already made major contributions to treating diabetes, as well as other health issues.
You're clearly not an objective analyst or else you wouldn't so freely use the loaded words that you do, such as "sins," "absurdity," "smoke and mirrors." And this list doesn't even get into the words you've used in previous articles.
Your comments about focus groups and NDA applications further underscore the lack of any professionalism (or perhaps common sense) in your article. Do you seriously believe that physicians would pervert their responses for a few dollars??? And why exactly would drug companies spend hundreds of thousands of dollars on market research if the research is as useless as you suggest??? As to the NDA application, have your ever even seen one???
You don't have a position in ORMP so it's difficult to understand your motivations. Oddly enough, too, your article, trashing MNKD, only shows up on the MNKD summary page. It doesn't even show on the ORMP page, which is supposedly the main subject of your article, let alone NVO, BMY, PFE, GOOG."
1) As George Rho pointed out, this was not a professionally written article. With the language she used, she clearly showed malice and bias towards MNKD.
2) The article didnt even show up on the ORMP page, only MNKD. Tells you who SA was targeting here.
3) She even deleted George Rho's well written counter position.....that my friends says VOLUMES about her character.
IMO this pathetic attempt to bash MNKD probably only had an effect on people with IQ's under 70 and regular subscribers to the National Enquirer. For the rest of us, I believe it has strengthened our position.
I mean who knows here? Maybe she is a hedge fund plant just trying to find a way to get some more cheap shares or even some for herself?
SAC's not going anywhere, they might have a few bucks less, but by far not out of business. J&J was just fined 2x as much as SAC....no big whoop, small price of doing crooked business.
The put out a Tweet the same day the FDA acceptance was announced that they expected it to be approved before Jan 1, 2014, but later deleted the Tweet. Now they have put the new Tweet out just stating that they expect approval before April 2014.
The fact that they are one of the few to interview Al and Matt, seems to lend some credibility to what they are predicting.
"Preparing the marketplace for the entry of a new drug or device is a process that begins in a product’s infancy. This is
the period in which misperceptions about a disease can be clarified, low awareness of a condition can be boosted, and
issues with current treatment options can be explored – all with the goal of readying the market for the introduction of
the new therapy. MCS has managed pre-approval communications for products in nearly every therapeutic category,
from a potential cure for the common cold to the first pill for gum disease. We have also supported more than 30 FDA
approvals/EU authorizations that have ranged from introducing the first agent in a completely new therapeutic class to
announcing line extensions for mature products"
Institutions will start accumulating now while they can get cheap shares. Without any other news this thing will be $9 going into next March/April. Add in European filing or possible approval in another less bureaucratic country, or even partnership or buyout, and top it off with one of the largest short squeezes in history, this thing will double if not tripple in the next 6 months.
I agree, things are just starting. Lots of catalyst on the horizon. PDUFA is only 5 and half months or less away. They didnt hire Greenfield and the MCS PR firm for nothing. The wheels are turning. MCS also represents Merck, so this is no mom and pop noobie PR firm.
Very interesting, Merck is also a major client of MCS. So now they have a top tier PR firm and also a partnership/merger firm both working for them.