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Finally listened to conference. Recommend all interested parties and holders of stock to do the same. Several little nuggets that is in my view, de-risking this "play" considerably.
First of all, for those who studied the data from the two successful Phase IIIs, it is evident that ALXA has a very efficious and safe product and novel delivery system. First in class...only type of drug that does what it does in this class. This is not the first time King has been "first" with introducing a novel mechanism in delivering a drug (i.e actiq for breakthru cancer pain) ALXA gave clearer guidance on filing of NDA (for US approval). Its expected early next year. Before it was a more nebolous "first qtr of 2010). Also, King stated the European filing is targeted for summer of 2010. He also said they will be ready for the FDA inspection of their manufacturing capability by end of 2009, before the NDA filing. King states that U.S. revenues would range from 300 - 500 million. I assume 300 million. 50% of that will be for in-clinic (in-patient) use for agitation. The other 50% will come later with the expansion of the label for out of clinic (out patient) use. For valuation purposes (these are my figures), i assume 150 million in peak revenues (conservative estimate). I use a multiplier of 3.5x peak sales and assume 60 million fully diluted shares. That gets us to aobut $7.00/share, with plenty of upside from there. That is one reason why i like this "play". It has largely been stripped of risk, with considerable upside as others begin to discover it. King also said that all 5 non pivotal safety studies have been completed for the NDA filing. We know the results of three of these as they were reported in the last qtrly report. That went well. The last two are now finished and will be reported in early November when they present their 3rd qtr report. This is consistent in how they report out this type of information. King said they are very much on track for their NDA submission. My sense is these final two studies are fine. They have cash that will take them to the 2nd half of 2010 and also expect partnering dollars to offset the need for any return to the market for a raise. As it relates to parterning, King provided guidance that parternship(s) will be in place prior to NDA filing. He said the several parterning candidates they have spoken to have expressed interest in participating in the NDA process. The lack of daily volume is one thing i would like to see improve, but taken as a whole, ALXA...its quality lead product...its novel delivery system which applies to hundreds of drugs...its exceptionally experienced leadership team...and de-risked phase of development....all these things makes for an attractive off the radar "play". Rating :
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Insights from JMP Conference
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paradigm.sh... |
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6-Oct-09 07:21 pm | ||
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WHY IS THIS UP IN THE AH?
=-BAMMER
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tripups_200... | Rate it | 6-Oct-09 07:53 pm | ||
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CEO bought 64,655 shares at $2.32 (Form 4 not...
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drbob601 | (1 Rating) | 7-Oct-09 01:12 am | ||
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Nice summary of the conference. I know what's her...
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john_welsh_... | Rate it | 6-Oct-09 09:33 pm | ||
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I think you came in at an excellent cost basi...
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paradigm.sh... | (1 Rating) | 7-Oct-09 08:49 am | ||
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Excellent recap Paradigm. Thank You. I listened ...
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cpneln | Rate it | 7-Oct-09 08:54 am | ||
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I have watched King on video and several time...
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paradigm.sh... | (1 Rating) | 7-Oct-09 09:16 am | ||
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Thanks for the summary of the presentati...
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bookerone20... | Rate it | 7-Oct-09 09:26 am | ||
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good post - thanks
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novice787 | Rate it | 30-Oct-09 07:52 am | ||
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Great post! It appears everyone is holding shares ...
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bookerone20... | (1 Rating) | 1-Nov-09 12:04 pm |
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