- Ultra-thinly traded nano cap Presbia PLC (LENS -17.9%) is down on almost a 10x surge in volume, albeit on turnover of only 80K shares, adding to the down move that started last week after the company disclosed that the expected FDA nod for its Flexivue Microlens may not happen for another year. Shares have slumped almost 40% since then.
- The company's original expectation was for U.S. approval this quarter based on 24-month data, followed by the submission of 36-month data in Q1 2019. The FDA notified it on October 5 that the 36-month results would be required for a complete review of the application. The company has until April 3, 2019 to submit the information, pushing potential approval into the last quarter of the year if all goes well.