The silence from the most recent CC is deafening.
I've never seen a company in this position in the approval process that was either partnered or was hiring their own sales staff. Also not a word on the fallback plan to form regional partnerships that was mentioned in a CC several months ago.
For those that have been around since the second CRL, I understood MNKD has a massive layoff. I'm guessing many of those positions were sales reps. Can anyone confirm?
I just hope that mgmt. doesn't wait until after approval to ink the deal (contingent on approval). It would pose no difference in terms for a partner. Otherwise, BP can choose to let MNKD flounder after approval, putting price pressure on the stock to get a better deal. GSK's CEO gloated in an interview how they waited for HGSI's price to dive, then stepped in with an offer to get them on the cheap. Let's hope MNKD's mgmt. is smarter than HGSI's, who spurned an offer from AMGEN at 30+, only to go end up taking less than 15/share AFTER approval.
Frontline: To Catch A Trader - Shows how rumors can spread quickly among traders. Whether long or short, looks like the rumor mill sprung a leak that day with some misinformation.
Most investors know that shorting a stock, or betting it will fall in value, entails the chance of huge losses. But knowing that is nothing like seeing it in action.
The ramp higher in Tesla TSLA -3.06% shares in the days since the electric-car maker reported a first-quarter profit has served as a vivid reminder of just how dangerous a game shorting stocks can be. It may also signal a shift to a kind of market environment that can prove particularly treacherous for those on the short side.
Even before Tesla reported, investors heavily short the shares had to be feeling queasy. In the time since Tesla said in early April that it had beaten its first-quarter deliveries target, its shares had risen 47%. When the stock jumped after the earnings report, the "short squeeze" looks as if it got unbearable.
Investors raced to buy back shares they had sold short. That intensified the stock's move higher, prompting even more pessimistic investors to throw in the towel. Tesla's shares rose 53% in three trading days, taking its market value to a peak of $10.1 billion, from $6.4 billion. In turn, shares of other heavily shorted companies, like InterOil IOC -0.81% and Questcor Pharmaceuticals, QCOR -9.96% also rallied. That is an indication some traders are actively looking to buy stocks with high short interest, posing an additional risk for short sellers.
Perhaps MNKD has at least two or three BPs thinking they are first in line for a partnership after approval. If there is any corruption in the FDA process, better to get as many BPs on your side going into approval. Just don't provide any hints that you're playing one off the other, hoping that they all use whatever influence they have to make approval a reality.
Net asset value (page 47 of the year end report) shows net asset value increasing from 21.86 to 23.74. So the overall value of the assets in the fund are still increasing.
Bing this "fda pre-approval inspection slide" and open the first hit : Inspections of CBER Regulated Products - U S Food and Drug. Seems the easiest read to get a quick picture of the process.
The lower they can keep the price, the lower the price of covered calls. From the options activity, they are predicting an upside from 9 to 15. Yes... they win both ways. They lose if the stock doesn't pop high enough, if the decision is good.
The "shorts" are also long, holding lots of covered calls. They are playing volatility. They aren't betting MNKD fails, they are betting it swings hard one way or the other based on which way the decision comes down.
Why just puts? Why not sell covered calls and try to cover the cost of your puts?
One advantage of high short interest is the call price is looking really good. Seems the shorts want to limit their upside loss should MNKD go parabolic on approval and partnership announced back-to-back. It's providing a less risky investment environment for those of us that are long with a substantial percent of our $$$ invested here.
Trading on insider information seems to be pretty well known to occur with regular frequency. Do a Google on Expert Network(s). If you're really interested, go to the PBS web site and watch one of the recent Frontline episodes on Steve Cohen. I found it highly entertaining (but I'm a big Frontline fan). You probably saw his employee Martoma was convicted a couple weeks ago for trading on insider information.
Glad you only made a tiny investment in VTUS and didn't go all in. I think Kitty (on VTUS board) tool a real thumping. Of my five individual biotech stocks, that was the only one I thought was a sure thing. Just goes to show regardless of the evidence, never can tell in biotech. I guess I got cocky after daring to hold TSRX then ATRS through the big event with success in both cases.
Still holding MACK.
Ummm who cares? All that counts is that study results could be released any day now. Mgmt said mid Feb. We're just about there. And if they're late, that typically bodes well.
FDA approved Exhubera and requested same trial be run post approval. Seems MNKD is anticipating approval and just being proactive. Uh... and if you listen to all the CC's mgmt. has mentioned this trial.
As far as copying patented drugs, in at least the HIV market, the top drug (Atripla) has been copied and sells for $150/month from Cipla (Viraday). However, it hasn't made a dent in the profits of Gilead.
Good luck... you probably already know this, but the PDUFA is probably not until 2015. I hope to roll my VTUS money into APPY then from APPY into MACK.
FYI, I have followed this guy (siamesekitty) on TSRX and now VTUS. He just made about $5M on SNTS
If YAHOO deletes this link, search the VTUS for the work paydirt or pay dirt to see his post.
And I would like to bring your attention to the stock VTUS. You can grab some of this one BEFORE great Phase III data for anal fissures topical pain medication is released. This one is a slam dunk as they already ran a large successful phase IIIA. Also the same medication is already popularly used in a form compounded from pills at the pharmacy. I cannot see how this one can go wrong.