final questions to odac, page-5

These questions are pretty much a rehash of those put forward by the FDA in Feb.

There is updated clinical trial data which I am assuming will be presented by CXS to ODAC tomorrow which includes 97 patients instead of 66. The updated data demonstrate (according to CXS)a significant increase in major cytogenic responses.

Also, they should present data about patients in Eurpoe already receiving Omapro and other studies they have completed re safety.

The key also is for CXS to successfully argue that the responders removed by the FDA should be included. CXS have the opinion that the FDA's view on this is not correct. They will need to convince ODAC this is the case.

The one thing in CXS's favour is that they have had since early Feb a list of what the questions/concerns will be. They seem confident in their preparation for tomorrow that they can address all of the FDA's concerns.

As a comparison I have reviewed past NDA's and the questions poised by the FDA run very similar. I have seen much worse initial reviews by the FDA only to have ODAC unanimously vote in favour.

It is now in Greg's (and others) hands to convince ODAC. Until the results come out I am betting that they can do it. It's a risk, but I'm in it till the result comes out.