TSXV:TRL.H - Post by User
Post by
LTOWNERon May 26, 2014 9:18am
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Post# 22597488
Some Crouching Too :)
Some Crouching Too :) So as stated we know for sure there will be no early Compleo FDA Approval today, it being Memorial Day in the US. The independent research group has had the Tefina data for two weeks now but we do not know whether this group also is in the US. And although they were asked to 'speed up', Trimel has no control over whether the release of the Tefina Report meets the end of May deadline. Could be close or over.
On the whole the market will be expecting an Approval, with a small margin of error for the always present FDA risk. It is comforting that Rossi said FDA final labeling discussions were 'winding down' March 8. That and his overall optimism on the issue of Approval doesn't sound like there are any major issues with labeling. Which makes me hopeful there will be no Black Box Warning. I don't think Rossi would sound so positive if the FDA was insisting on a warning. There is no rational reason to expect any transference issues with Compleo but the FDA is not always rational.
Lots of penny investors and day traders around for the excitement and there's a place for all kinds of investors. The big money will wait for the risk to decrease.