I attended the teleconference and have the following to say:
Greg Collier addressed current issues and questions with quiet confidence...
Relevant points discussed:
- "TYPE A meeting" with FDA in early June to to address vial sizes, diagnostic testing and number of patient concerns
- the meeting will result in an agreement as to what needs to be done in order to approve omecataxine (approx timeline will be known)
- diagnostic tests already exist and Chemgenex will not develop new ones (use existing for approval)
- Greg noted the they have now 103 patients in total from the initial 66 trial prior to previous meeting with ODAC (addresses one of the concerns mentioned above)
- Europe expected to generate $100 million in royalties, hope is to use these funds to rollout the commercial launch in US
- EU milestones on target, no delays expected at this stage
- Further capital raising not expected at this stage (costs and cash burn kept at minimum until drug approved)
- ORBIS taken on more stake in CXS when share price dropped significantly (this was NOT Greg's comment; but from a reporter)
- Directors' dissapointed with the current share price and blame AU market in-experience with Biotech company processes; particularly drug approvals etc.
- AU market over-reacting, Greg notes all other Biotech companies went through same process for approval (normal process)
- Greg confirmed previous estimates of potential market is accurate (i.e. from 30,000 patients treated with Gleevac, 40% develop resistance over 5 yr period, and 20% of those have the T315i mutation)- my estimate: approx 2400 patients @ $80k per annum (in US alone)
- Third line drug testing and study ready for submission to FDA (waiting for Omecataxine approval first)
in addition to patients above, there are those who do not respond to multiple TKI's (don't know numbers here - but could be significant)
One other important point raised, is the Fact that the committee would have voted in favour of approving Omapro had they voted on Efficacy and safety of Omapro. VERY ENCOURAGING!
For any of you who participated; please fill in any gaps as I am writing from memory.......
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