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Celsion Corp. Message Board

  • niwrad1809 niwrad1809 Feb 1, 2013 1:53 PM Flag

    For what its worth ...

    ... I believe there is good money to be made with DVAX this month. PDUFA is scheduled for Feb 24. Adcom gave a thumbs up on efficacy and thumbs down on safety in November and the stock plunged. However, I recommend listening to the panel because thats not the whole story. The thumbs down was the result of the panel making a larger point about the racial make-up of studies. They slammed DVAX for having a sample that didnt reflect the racial distribution of the US. I personally disagree with this assessment. There is a good argument to be made that studies should reflect patients, which may or may not be the same as the US racial make-up, however, it was cowardly to punish a small biotech for this. It would have had much more impact to go after big Pharma on this point. In addition, the FDA agreed with my assessment. At the hearing they had a representative who said that DVAxs study far exceeded their expectations. To date, it is the largest HepB study and the safety profile is at least as good as what is already out there if not better. For those of you who took a big hit with CLSN, but want to stay in the game, I suggest looking into CLSN as they have a near term catalyst and I believe they have been unduly punished, which should stand to give them a pretty big bump come the end of the month.

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