Below is the extract from a announcement by the company:
Commenting on the correspondence from the FDA, Greg Collier, PhD, CEO for ChemGenex said, "The complete response letter from the FDA provides the initial guidance towards our endeavor to bring a new therapy to CML patients who harbour the T315I mutation and currently have very limited or unsatisfactory treatment options. Because the principal issues raised by the FDA were similar to those discussed during the 22 March meeting of the Oncology Drug Advisory Committee (ODAC), and based upon our interpretation of the scientific requirements underpinning the complete response letter, we are confident that we can work in a positive manner with the FDA to address the outstanding matters. We appreciate the constructive comments made by the agency in the response letter and ChemGenex will seek a meeting with the FDA to discuss and find agreeable solutions for each of the FDA's requests."
My comments below:
Why not publish the so called "complete response letter"?
Greg said this is an "Initial Guidance" toward Omacetaxine being approved: how many more guidances do you expect to get?
"Confident to be able to work in a positive manner".... what does that mean? how long do you expect to be working on this? and lastly
Chemgenex will seek a meeting......to find agreeable solutions to EACH of the FDA's requests" Can we have Each of FDA's requests published?
This is the least CXS Management should release to investors so they can assess their own risks with regards to investing in CXS.
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