Z, FDA approval, in very large part, originally meant the final step before revenues. With full steam ahead closing in now, in EU, revenues can begin without approval. Revenues, in essence, means more than FDA approval. Afterall, approval w/o revenues is nowhere near as valuable as revenues w/o FDA approval.
Ya might say, the market itself puts all things in it's priority, and revenues has always been 'the bottom line', and top priority. Institutions prefer solvency (ie; revenues) far more than patents, licensing, approvals, etc.
Remember, the new recent high of 2.39 was not achieved by any actual anticipated date of FDA approval. It was achieved by a compilation/combination of ALL fundamentals, and the proximity of EU revenue. New developments keep occuring, fundamentals keep growing, hence, interest will continue to grow.
Don't be fooled by a temporary retrace. It has nothing to do with FDA approval.