Have been a shareholder for a number of years, so I follow this company fairly closely. The brief notes below are from my brokers latest research.
The market regardless of the potential for FDA problems re CF302 , doesnt realise that the Euro registration situation is entirely different imho. In the PXS investor conference call (available on their web site) the company clearly confirms that the EMEA have only requested CF302 safety data.
*****************
Potential impact on the EU review process
Following the release of Phase III CF EU clinical trial results (CF301) in May 2009, a marketing
application was submitted to the EMEA (under the centralised procedure) in October 2009, with a
decision on the application due 4QCY10.
We understand that the EMEA, while closely monitoring the CF302 trial, has only requested the
safety data from this trial. In our view, the safety data from this trial is robust and should lend
additional support to the EU application. Consequently, we expect no negative impact from the
outcome of the CF302 trial on the EMEA approval process
Hope this is of some help.
Wr
Tu
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