I believe a similar question was asked in the conference call. My interpretation of the CEO's comments is that trials are not expected to be repeated:
Question (Miles): My question relates to the test itself, the way it is validating, is it a test that you have already used in your trials, or is it a new test? And I have got a second question too.
Answer (Greg-CEO): There are a number of tests that are used in the discussions with ODAC today and one of the things that was discussed and pointed out was that the tests that have been used are quite basic sequencing tests and they use standard sequencing technologies that have been available for many, many years. What the FDA are now looking for though is validation of these standard tests to make sure that the reproducibility of the test as well as the cutoff point if you like for identifying these mutations are standardised.
Queston (Miles): But were these tests used in the trial, these particular validation tests for Omapro, for the mutations?
Answer (Greg-CEO): Yes, the clear answer to that is the tests that were used in the trial were predominantly based on mutation based on sequencing to identify mutations so if 95% of the patients had a standard sequencing test done. Now most of the tests done, there are various tests available, commercially already, and most of the tests do use the basic sequencing approach. In our particular trial, as we mentioned in the panel today, we have used a number of different tests to identify a patient but most of these were based on clear sequencing.
Question (Miles): My second question then is, once the test is validate and approved by the FDA, does that mean that you have to go through the trial process again or does the trial process stand?
Answer (Greg-CEO): No we don't expect to go through any new trials or trial process again. I mean this is quite a separate issue to be discussed first to make sure that the test is reproducible and reliable, and then as you would have heard the ODAC panel talk about today, they were quite positive about the clinical results that were found in the trial but it is important...FDA has emphasised now, in this new era of personalised medicine that it is important to make sure that the diagnostic tests that are out there in the market are validated and made useful. That was a clear message from the FDA I think ....
CXS Price at posting:
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