The FDA has handed Ocular Therapeutix Inc (NASDAQ:OCUL) a Form 483 detailing observations made during the second review of the manufacturing site by a new investigator. The Form 483 contained inspectional observations focused on procedures for manufacturing processes and analytical testing, related to manufacture of drug product for commercial production.
Cantor analyst Elemer Piros commented, “We believe the items discussed on the call remain manageable and do not delay the current regulatory timeline. Several issues relating to particulate matter and manufacturing process were identified, including completion of an already ongoing investigation and enhancement to operator training. Ocular has begun to prepare responses for items identified and believes it will be able to respond within the 15-day period, which will required to prevent delay of the PDUFA date. Management highlighted on the call that approximately 90% of inspections lead to a Form 483, and their belief that a re-inspection would not be necessary in the future based on the current feedback. In addition, we note that the corrective action plan to address prior issues was confirmed by FDA.”
Piros reiterates an Overweight rating on Ocular shares, with a price target of $35, which represents a potential upside of 299% from where the stock is currently trading.
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Elemer Piros has a yearly average return of -4.3% and a 47% success rate. Piros has a 17.1% average return when recommending OCUL, and is ranked #4080 out of 4561 analysts.
As of this writing, all the 6 analysts polled by TipRanks (in the past 12 months) rate Ocular stock a Buy. With a return potential of 191%, the stock’s consensus target price stands at $25.50.