Mike J. asks, "Help!!! What the heck is wrong with Amarin (AMRN)?" Nothing is wrong with Amarin, unless you're trading the stock. The fundamental outlook for the company and its triglyceride-lowering drug AMR101 remains strong.
Thomas L. emails, "Now that Neoprobe ( NEOP) has filed for Lymphoseek's approval, can you give us your prediction? Who's right, the company or Martin Shkreli?"
Ha! Great question. You're putting me on the spot but I lean toward the company being right. I have respect for Shkreli, the hedge fund investor who is now rather famous (or infamous) for taking a public stance on his Neoprobe short, but in this case, I predict FDA will approve Lymphoseek as a new lymph node-mapping agent.I think there is some merit to the regulatory concerns about how Lymphoseek was studied only against vital blue dye and not the true standard of care -- vital blue dye and a radio-labeled sulphur colloid. But FDA did recently approve another radio-labeled sulphur colloid from Pharmalucence based on data collected from historical studies that mainly compared sulphur colloid against vital blue dye alone. This FDA approval seems to support Neoprobe's contention that it conducted the proper studies of Lymphoseek by using blue dye as the only comparator. Shrkeli disagrees and continues to short Neoprobe. He thinks FDA will reject Lymphoseek. In fact, he's trying to convince the agency that it shouldn't even review the lymph node mapping agent at all. Neoprobe filed its approval application for Lymphoseek on Aug. 10. FDA has between 60 and 74 days to accept the filing for review, so we'll have an early indication of who's right or wrong by early to mid-October. An FDA acceptance of the Lymphoseek filing does not guarantee final approval in June of next year, but it will be a positive signal and I'd expect Neoprobe's stock price to move higher. Obviously, if FDA sends the Lymphoseek filing back to Neoprobe, i.e., issues a refuse-to-file letter, the company's stock price is going to take a hard hit.
MIF456 emails, "I didn't see you comment at all on Avanir Pharmaceuticals' (AVNR) results. The stock is down so I wonder if you agree with that assessment or think that there is something good happening with Nuedexta. Thanks in advance." The Avanir numbers for fiscal third quarter were better but still not good enough. Nuedexta gross sales were $2.2 million in the quarter, up substantially from the previous quarter and generally in line to slightly better than consensus expectations.
A reminder that the next Biotech Stock Live Chat is scheduled for Friday, Aug. 19 at 12 p.m. ET. -- Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: email@example.com.