TG Therapeutics Inc (TGTX)

[postmeridiem]

I certainly hope it is approved, for financial and personal reasons! And I agree with TGTX dropping the SPA on the GENUINE trial - the slow enrollment and PFS endpoint would have required far too long to get the final results.

I just don't think approval is anywhere near certain. The FDA has a history of changing the rules without warning - there is no guarantee they will accept an ORR endpoint now even though they used it for past approvals in the same indication.