conference call

Just got off a conference call with Greg Collier & Adam Craig (scientific officer). Key point as follows:

o It was not a surprise that the FDA were seeking a validated diagnostic test for the T315 mutation. We have been working with the FDA for several months and will receive guidance on specific requirements from them on 9 April.

o Although ODAC did not vote on efficacy & safety they were very positive and acknowledged that Omapro cateres for an unmet need. They also said if the question was posed to them re safety & efficacy they would have approved Omapro.

o Greg said that the FDA only wanted a vote on the diagnostic so ODAC's hands were tied to this vote only.

o There will be no impact on EMUA submission. They are in constant discussions with authorities and everything is still on track for Eurpoean approval.

o They will still work in parallel with FDA to address diagnostic test and final approval.

o The market has misunderstood ODAC's vote. We don't see this the way the market sees it. The reviews and comments from ODAC was etremley positive and although the diagnostic issue is frustrating we see it as part of the necessary steps one has to go through to get a drug approved.

o There are commercial tests already available (clear sequencing). The FDA want to validate these tests so we will work with these providers and the FDA to ensure requirements are met.

o We don't expect to go through any new trials again. As mentioned the ODAC panel were very positive and would have approved Ompapro is the question was related to efiicacy & safety profile.

That's about all I got. If anyone else was plugged into the telecon please add.