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Friday, February 15, 2013 12:43:03 PM
I note that Mgmt. told the author, i.e. Dr. Joe Pantginis, the same thing in early Jan. that I heard and posted on Jan 31 regarding timing of the big PR update on the 2nd line investigation. Here is Dr. Pantginis' statement on Jan 14:
Management has indicated that they expect to complete the analyses from the 2nd line study in the next few weeks, which is expected to trigger the request to meet with the FDA face to face.
What confuses me is Dr. Pantginis' last statement in the same paragraph, which reads:
It is important to point out that the data analyses to date were from present data follow up and not from the data presented in September, so patients have approximately 3 more months of follow up time and we look forward ro receiving the updated survival numbers.
FTM-- Do you understand the underscored remark? How could the Company publish in mid-February a definitive MOS number that will be given to the FDA for EOP2 meeting purposes if "patients have approximately 3 more months of follow up time" ?
I am wondering now if they expected 80% of the patients to have died by mid-February (which would be the industry norm for determining a final MOS number), but the delay in putting out the PR is because 80% of the patients have still not "evented."
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