An emerging pharmaceutical company focused on the development and commercialization of novel, proprietary products for the treatment of acute and intermittent conditions.
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I've done very poorly on my previous outperform pitches on Alexza, and I could very well be green thumbing too early again. I have to tag the stock because I think there's a high likelihood that it will run up again before the next Adasuve PDUFA on December 21, and also about a 70% likelihood that the drug will be approved the third time around. I wouldn't consider putting any real money in this until after the Q2 report on August 8, when it will be clear how much cash the company has and if there's any likelihood of another dilutive financing before the PDUFA.
The fact that Alexza was able to resubmit the Adasuve NDA only six weeks after the CRL indicates that the company accurately described the FDA's most recent concerns as limited to a specific manufacturing concern. A REMS is in place to deal with the original rejection due to bronchospasm. Of course, the FDA can always resurrect the bronchospasm issue or bring up a completely new objection to the application, but I think this is unlikely. As with Arena's Belviq and Discovery's Surfaxin, I think the FDA has made their point that they aren't exactly endorsing the use of Adasuve and will leave it up to the medical establishment to determine if its use is worthwhile.
If I'm correct in my thesis, watch for the flip turn after FDA approval. I'd be amazed if anyone buys this crap.
Bought 5000 shares today at 2.98 for the GBMB. First real bet ever on this dog. Now hopefully the Day 180 List of Outstanding Issues from the EMA in September won't look too ugly and interfere with the run-up before the PDUFA in December.
Excellent. well played...
Sold all 5000 shares today at 4.96 for a GBMB profit of $9900. Kind of disappointing price action towards the end but fortunately I got a very good entry so I didn't have to time the top perfectly. I don't have a good feeling about the CHMP opinion and I'm suspicious about the company's claims to have resolved the two major objections in the 180 day LoOI so quickly. On the other hand, I still feel the FDA is likely to approve on 12/21/12, after which the stock will bump sharply and then tank as commercialization becomes the new story. If CHMP recommends against approval I might buy January calls to play FDA approval, otherwise I'm out for the foreseeable future.