Replies to post #2937 on Halozyme Therapeutics Inc (HALO)

[Skeetz99]

Rod:

Are you implying that HALO will get FDA approval for the Hylenex Label change since its over 60 days?


Another example of fast FDA required response times is Hylenex label change to include insulin pump data. Regs say Halo can submit label change without prior authorization and FDA has 30 days to respond. Lack of response within 30 days is automatic approval. Halo is in talks with FDA over 60 days already. Nothing is ever fast, simple or easy.