The problem is, trying to hold FDA/EMA to published timelines never work out that fast. There are always time stops, exceptions, another section of regs, etc, etc, etc. How long will it take Halo to compile/submit required data? Can the trial resume? Will the efficacy be so good that trial opens path to phase III. The possibilities are many but no one has the data and we will not know until it is resolved.
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.
Look at Baxter having to wait until December to submit preclinical data for resubmission. They used same data in EMA submission/approval 7 months earlier. Why the delay?
Oh well, we patiently wait. Good thing Halo is not a one trick pony.
Good Luck,
Rod
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