Your impression is wrong - EMA is more difficult, they consider cost/benefit/risk, FDA only looks at risk/benefit. Ask any ARNA shareholder how easy (hard) it is to get a drug approved overseas - they've already been rejected in EMA, Switzerland (where they MAKE THE PILLS), and on hold in Canada/Mexico. You folks can drink the Kool-Aid if you want, but MNKD will live or die on US-only sales for the next 2-3 yrs.
Small problem with your math - Sanofi has to file for drug approvals in ROW, will take years, and no guarantees that they'll get approval to sell - in fact, I bet that the EMA rejects over lung cancer concerns, just like they rejected ARNA/Belviq over rat cancer concerns. And many US diabetics are poor, no way they shell out $100/mo when generics cost so little. Then there's the problem of getting insurers to cover it - with the ACA cost cutting stuff, recent news of CVS/ESI dropping 100 brand name drugs from coverage, Sanofi faces an uphill battle on many, many fronts.
Not true - there are built in clock stoppages in the EMA process that greatly up the total time past 210 days. NAVB submitted an app for LS in Dec 2012 and don't expect a decision until Q3/Q4 2014.
Nice to have another short data site to check, but MM's numbers don't match shortanalytics - close in some cases, off by tens of thousands in other. Not sure why that is since they both fetch the same data?
Lots of places to see the Form 4 for Wilkinson's trade of 50k shrs, won't post a link, Yahoo would make it disappear - it was a straight sale, not part of a Rule 10b5-1 trading plan - brought in $568k, but don't know how much he netted. He got ~ 173k free shrs (option grants) from 2009-2013.
Interesting - just saw an AH news blurb announcing a big new agreement between my other tech stock, TSRA, and Micron - could have a two headed tech monster on my hands here!
I posted yesterday that Micron may be the other mystery bidder - comment was gone when I checked the thread today - huh?
HZNP should be able to cover minimum royalty payment despite that CVS/ESI are dropping insurance coverage - from their Q1 10-Q:
"VIMOVO gross and net sales during the three months ended March 31, 2014 were $50,010,000 and $34,007,000, respectively, after deducting sales discounts and allowances of $16,003,000, including co-pay assistance costs of $4,587,000."
POZN gets 10% royalty on NET sales, min $5M in 2014, min $7.5M from 2015 on - net for Q1 was $34M * 10% - $3.4M, subtract 30% of sales coming from CVS/ESI, you get net sales of $2.4M/Q, or $9.5M/yr - easily covers POZN payments. Huge over-reaction by the market, they didn't look at the numbers, shoot first ask questions later.
From shortanalytics website, 25% of POZN shorts covered yesterday - that's actually good news, surprised more didn't take the opportunity to cover, ain't going lower than yesterday any time soon.
You folks are confusing CVS Caremark, the insurance drug provider (and Express Scripts), with CVS the drugstore chain - insurance plans that use those providers, like for Medicare Part D, will no longer cover Vimovo - Rite Aid and Walgreens and Walmart may pick up sales because CVS will no longer sell V, but that won't change the fact that some 20% -30% of patients will no longer have V on their formulary - those other pharmacies are not part of a drug insurance plan.
June OPEX? Hmm....I thought they were the July 18's.....why delay the announcement by a month? IIRC 10% owners must report much faster than that?
Just got this alert - PIP sold the calls on Jan 21 when pps was $8.75 - PAR Capital still owns 3.36M shrs - PIP is a hedge fund managed by PAR Capital, alert system has wrong name, but if you check the SEC filing you'll see the correct one. Weird thing is why were they called with the pps at low $8's end of last week? Dunno how the buyer made money here.
PAR CAPITAL MANAGEMENT INC sold 492,600 Common Stock @ $9.00 per share.
PAR CAPITAL MANAGEMENT INC is a 10% Owner at POZEN INC /NC (POZN). This transaction represents a 6656.7568% change in their holdings.
This transaction became public at 3:55PM today but actually occurred on Saturday.
These shares of common stock were sold in connection with the exercise of call options (obligation to sell) that the reporting persons sold on January 21, 2014. These securities are or were held by PAR Investment Partners, L.P. ("PIP"). PAR Group, L.P. ("PAR Group") is the general partner of PIP. PAR Group disclaims beneficial ownership of the securities except to the extent of the pecuniary interest, if any, in such securities as a result of PAR Group's general partner interest in PIP and contingent right to a performance-based advisory fee. PAR Capital Management, Inc. ("PCM") is the general partner of PAR Group which is the general partner of PIP. PCM disclaims beneficial ownership of the securities except to the extent of the pecuniary interest, if any, in such securities as a result of PCM's general partner interest in PAR Group.
RF Micro Devices, Inc. (NASDAQ:RFMD) options volume is running at 15 times the usual intraday pace this afternoon, with calls outstripping puts by about a 19-fold margin. Meanwhile, the stock's 30-day at-the-money implied volatility has popped 2.9% to 48.3%, indicating elevated demand for short-term options.
Nevertheless, RFMD's most active option by far is the longer-term January 2015 11-strike call, where roughly 17,400 contracts have traded. According to data from the International Securities Exchange (ISE), a significant portion of these contracts are being bought to open for a volume-weighted average price (VWAP) of $0.95. In order to profit at expiration, today's speculators need the shares to rally past $11.95 (strike plus VWAP) at the close on Friday, Jan. 16, 2015. Gains are theoretically unlimited beyond this breakeven point, while potential losses are capped at the initial premium paid, should RFMD finish below the strike at January 2015 options expiration.
On the charts, RF Micro Devices, Inc. (NASDAQ:RFMD) -- which is scheduled to report fiscal first-quarter earnings this Thursday evening -- has tacked on 4.7% to trade at $10.76, just shy of its 10-year high of $10.82, touched moments ago. Taking a step back, shares of the tech firm have more than doubled on a year-to-date basis.
Baloney. Labeling issues can hold up approvals and/or kill the drug's potential sales - look at MNKD's label, awful. The real issue here is that it doesn't appear the facility problem is absolutely fixed yet - Class 2 is the more serious type of problem, Class 1 is ~ 2 months. From the PR:
"Issues raised during an audit of the manufacturing facility producing an active ingredient used in the manufacture of the products were the only deficiencies noted in the Complete Response Letter (CRL) POZEN received on April 25, 2014. == If such inspection deficiencies are not satisfactorily addressed by the new user fee goal date, the FDA could issue another CRL.
Volume is pitiful - checked the raw time/sales data, only a handful of trades 2000 shrs, a few ~ 5,000, and a possible sign of a short cover seconds ago - a 19k block that sold at the ask, not the bid. Check shortanalytics later tonite and next two days to see covering, probably new shorts at the peak too.
If you're suggesting POZN may try to sue the FDA because of the #$%$ they pulled, forget about it - they are immune from lawsuits except for extremely limited cases, none of which apply to us or POZN. They won't talk to you because the info is material news, they'd be breaking SEC laws if they said a single word before the facility passes reinspection.