TGTX amended the GENUINE trial to evaluate only the overall response rate of patients receiving the drug combination, rather than measuring how long patients live with the disease following treatment.
Also, they reduced the number of patients from 200 to 120. Their PR said the FDA has agreed that Overall Response Rate (ORR) data from the revised GENUINE study can be used to request a pre-BLA (Biologics License Application) meeting. Using this data to request a pre-BLA meeting is a far cry from the FDA approving a modified SPA. This meeting has not even taken place yet, and there is no guarantee the ORR data with fewer patients will be accepted as adequate for a possible approval.
If you can show me where the FDA agreed to amend the SPA to accept ORR and fewer patients after TGTX made these modifications, I'd like to see that.
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