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This is the (to gekko) offending passage on page 2: (of course he doesn't mention that the studies were in patients who already had COPD or asthma).
"AZ-004 (Staccato loxapine). Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. During the third quarter, Alexza completed the enrollment and data analysis of the two remaining AZ-004 non-pivotal safety and NDA-supporting studies. These studies were a pulmonary safety study in subjects with chronic obstructive pulmonary disease, or COPD and a pulmonary safety study in subjects with asthma.
Alexza completed a Phase 1 placebo-controlled study in 53 subjects with predominantly moderate-to-severe COPD and a Phase 1 placebo-controlled study in 52 subjects with mild-to-moderate persistent asthma, to assess the pulmonary safety of AZ-004 in these populations. The studies employed double-blind, parallel-group designs. In each study, subjects were given two doses of Staccato placebo or 10 mg AZ-004, ten hours apart. Spirometry testing and other safety assessments were performed at several time points up to 24 hours after the second dose. The primary safety measure was FEV1 (forced expiratory volume in one second), a standard test of lung function. Decreases in FEV1 versus baseline, respiratory symptoms, and use of a quick-relief bronchodilator occurred in both treatment groups, but were more frequent in each study after treatment with AZ-004. There were no serious or severe respiratory adverse events. All respiratory symptoms developing after treatment were either self-limiting or readily managed with the inhaled bronchodilator. " http://www.sec.gov/Archives/edgar/da...999exv99w1.htm
This is the (to gekko) offending passage on page 2: (of course he doesn't mention that the studies were in patients who already had COPD or asthma).
"AZ-004 (Staccato loxapine). Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. During the third quarter, Alexza completed the enrollment and data analysis of the two remaining AZ-004 non-pivotal safety and NDA-supporting studies. These studies were a pulmonary safety study in subjects with chronic obstructive pulmonary disease, or COPD and a pulmonary safety study in subjects with asthma.
Alexza completed a Phase 1 placebo-controlled study in 53 subjects with predominantly moderate-to-severe COPD and a Phase 1 placebo-controlled study in 52 subjects with mild-to-moderate persistent asthma, to assess the pulmonary safety of AZ-004 in these populations. The studies employed double-blind, parallel-group designs. In each study, subjects were given two doses of Staccato placebo or 10 mg AZ-004, ten hours apart. Spirometry testing and other safety assessments were performed at several time points up to 24 hours after the second dose. The primary safety measure was FEV1 (forced expiratory volume in one second), a standard test of lung function. Decreases in FEV1 versus baseline, respiratory symptoms, and use of a quick-relief bronchodilator occurred in both treatment groups, but were more frequent in each study after treatment with AZ-004. There were no serious or severe respiratory adverse events. All respiratory symptoms developing after treatment were either self-limiting or readily managed with the inhaled bronchodilator. " http://www.sec.gov/Archives/edgar/da...999exv99w1.htm
Take-over chatter was buzzing regarding Mankind today (MNKD)... I was eyeing this one the other day to start scaling in but missed this 9% move!
Shares of MannKind Corporation (MNKD) have rallied more than 9% so far today, with the stock beating a steady path higher throughout the session. No news in particular seems to be driving MNKD higher -- although Tiernan Ray of Barron's reports that unsubstantiated buyout rumors could be the source of today's positive momentum.
However, the stock hasn't yet rallied high enough to challenge resistance at its 10-month moving average. This stubborn trendline ceiling has held MNKD in check since March, ushering the shares to a year-to-date deficit of more than 30%.
Nevertheless, call players have flocked to MNKD today. Call volume has surged to nine times the norm, with roughly 26,000 contracts changing hands. Most active are the equity's February 2011 10-strike call, with 4,395 contracts trading, and the October 7 call, where 4,379 contracts have been exchanged. With MNKD hovering near $6.70 at last look, both of these popular calls are out of the money.
Given the equity's breakout rally today, it's entirely possible that short sellers are the driving force behind this ramped-up call volume. With nearly 21% of the stock's float sold short, there are plenty of bearish bettors who might be looking to hedge against a continued climb by MNKD.
Good for you. I have a full position and no free cash. These da## biotech stocks are not for the faint hearted. Somebody's doing a lot of manipulating, selling. Maybe the shorts loading up.
Analysis in progress. But I like this stock at about 14.53 today for partial position. Didn't want to keep you waiting. I'm putting in a bid there also.
River,
Hope you got it at your price. don't ya love it when the plan works out? (VPHM)
This is a useful lesson in risk management re. baby biotechs. I'm a bit of a gambler at heart, so I'm holding ALXA for now, not giving in to the temptation to buy more at this GA (god awful) price. They have been in constant discussion with the committee members at the FDA, so I'm hoping against hope that all the bugs have been worked out. CRY, all you shorts!
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