Friday, August 02, 2013 8:00:26 AM
We all know that will not be earnings for quite awhile; that's a given with most mid-stage biotechs. It would be nice to know the monthly cash-flow burn rate going forward, however.
Foremost, this conference call needs to be all about forward looking "guidance." Specifically, the roadmap how the delivery mechanism will be approved in the two major markets: Asia (China) and North America. As such, we need to hear the words "FDA" and "CFDA" during the conference call and what kinds of discussions Celsion has had with those two regulatory entities. (Note that SFDA has been changed to "China Food and Drug Administration.)
I'm hopeful that more HEAT study post-hoc data will be released, and that this data is ready to be submitted to the appropriate regulatory entities.
Without a path for regulatory approval, Celsion will likely remain stuck trading between 1.10 and 1.30. With negative news, it could gap lower towards its cash value of about 0.75/share. Good news of ANY kind will send the stock appropriately higher.
I remain bullish on the technology and the company, but we need to see some positive guidance from this conference call that will lend some staying power to any rally in the stock.
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