Portola Pharmaceuticals (PTLA) received a CRL from the FDA, pushing shares down sharply in pre-market trading. PTLA fell more than 10% in regular trading on Wednesday. In the CRL, the FDA has requested information related to manufacturing. The agency also requires more data to support inclusion of edoxaban and enoxaparin in the label. The FDA also said that it requires to complete its review of the clinical amendments to Portola's post-marketing commitments that were submitted recently.
While the CRL is a disappointment for PTLA longs, the issues raised by the FDA have nothing to do with andexanet alfa’s safety or efficacy. Therefore the sell-off post the FDA rejection looks like a buying opportunity. I will be adding PTLA shares to bring my average cost down. While the delay is a setback for PTLA, it does not have a significant impact on the bullish thesis.