Prometic: Still A Buy Despite The Delay In Plasminogen's BLA
seekingalpha.com
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Comment: No analyst has noted the destructive effect of the ~30 million-share short position. Not ONE. Very strange.
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The Delay
Prometic ( OTCQX:PFSCF) investors had a rough day, with a dramatic sell-off triggered by the Q4/2017 report, which announced a delay in Prometic's first BLA for congenital plasminogen deficiency. The delay results from the FDA requesting more Chemistry, Manufacturing, Controls (CMC) information. This update is provided in the report:
- The FDA’s review of the BLA raised no issues regarding the clinical data for the accelerated approval. The FDA has, however, identified the need for Prometic to make a number of changes in the Chemistry, Manufacturing and Controls (CMC) section of its BLA. These changes require the implementation and validation of additional analytical assays and “in-process controls” in the manufacturing process of RYPLAZIM™ (plasminogen). While Prometic is expecting to complete said implementation and validation in April 2018, it will be necessary to manufacture additional RYPLAZIM™ (plasminogen) lots to support the implementation and validation of these process changes. Prometic expects to complete the manufacturing of the additional validation lots in the summer of 2018 and anticipates being able to provide the FDA with such new CMC data for its review in the fourth quarter of 2018, which is beyond the Prescription Drug User Fee Act (PDUFA) date of April 14, 2018. The FDA requested that such CMC data be submitted as an amendment to the current BLA and has invited Prometic to also submit the long-term (48-week) clinical data at the same time instead of through the originally agreed upon supplemental BLA process. This process will allow the FDA to consider granting full-licensure under the current BLA. If granted, this is expected to allow a faster sales ramp-up from launch than could have been achieved had provisional licensure been obtained by the current PDUFA date. The Company continues to interact with the FDA and will provide a further update when it is in a position to disclose a new PDUFA date. The FDA indicated that the submission of the new CMC data will not impact the previously granted designations, including the Priority Review Status, the Orphan Drug Designation and the Rare Pediatric Disease Designation for RYPLAZIM™ (plasminogen) for the treatment of congenital plasminogen deficiency.
While the news of this delay due to FDA's CMC requirements is definitely not welcomed or liked by the investors, it is not totally unheard of.
For example, Progenics Pharmaceuticals, a US company, recently announced that the FDA has notified them that the agency will extend its review of their NDA by three months. The extension is the result of the submission of additional CMC information by Progenics, which will require additional time for FDA review.
Opinion: A nearly 30% drop in share price with a volume of over 30M shares was an overreaction by investors to this very disappointing news. The expectations have been high, and the waiting has been long and difficult for many Prometic longs.
Jim |
