Wilsons report before the news came otu didn't seem to think that the diagnostic test was a big deal. "The ODAC review has flushed out inconsistencies in the way T315I testing was
handled in the trial; even though all tests were based on the familiar PCRtechnique. This is new information that was not known before. FDA will push ChemGenex very hard on this issue and could require a companion diagnostic to accompany the product. This would not be difficult to obtain commercial
testing for T315I has been performed since 2006 and ChemGenex and a diagnostic partner could pursue a Humanitarian Device Exemption through FDAs CDRH, which does not require clinical trials or effectiveness testing."
On this basis I have bought a very small amount in a number of accounts to be eligble for capital raising as I figure they will need to raise capital.
Any thoughts on how difficult to get the diagnostic test up and running and approved?
Cheers
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Wilsons report before the news came otu didn't seem to think...
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