After remaining silent on Neoprobe (NYSE Amex:NEOP) the last few months, the cancer diagnostics company’s most outspoken critic and short seller has found himself back in the spotlight after the FDA accepted for review a drug application from the company.
And that critic — Martin Shkreli of New York hedge fund MSMB Capital — is still predicting that the U.S. Food and Drug Administration won’t approve Neoprobe’s radiopharmaceutical Lymphoseek next year.
(It’s important here to understand the difference between FDA acceptance and approval. Acceptance typically is no big deal — it just means that the FDA will conduct a review of the application. Approval is a very big deal, meaning that companies are free to begin selling the drug in question.)
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Shkreli said he wasn’t surprised that the FDA accepted Neoprobe’s New Drug Application for Lymphoseek.
“Not surprised as refuse to files are excessively rare,” Shkreli said in a brief e-mail exchange.
Shkreli also defended himself against charges that he was flat “wrong” about Lymphoseek from Adam Feuerstein, a columnist for TheStreet.com, in a sometimes-amusing Twitter exchange.
“As a father, I teach my kids to be accountable and admit their mistakes. Nothing wrong w/ being wrong,” Feuerstein said to Shkreli in one tweet.
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“If FDA rejects Lymphoseek, u can claim victory, but u lost 1st skirmish (NDA acceptance.) u should acknowledge, move on,” he said to Shrkeli in another.
Still, Shkreli wouldn’t back down, saying he never predicted that the FDA wouldn’t accept the Lymphoseek application. He just predicted the FDA wouldn’t approve it. (I’ve been searching for quotes from Shkreli that would contradict this assertion, but haven’t found any.)
“As a father, you know as well as I do, that asking someone to do something is different from expecting them to do it,” he said to Feuerstein.
Shkreli had earlier filed a citizen’s petition with the FDA, asking it not to accept Neoprobe’s application. Shkreli said he had concerns with the design of clinical trials for Lymphoseek, but Neoprobe’s army of retail investors charged that he was just trying to manipulate the company’s stock price for his own gain. For its part, Neoprobe dismissed Shkreli’s charges as “baseless.”
Neoprobe has said it expects an FDA decision on Lymphoseek approval next summer. We’ll have to wait until then to know whether Shkreli or Neoprobe and its investors will have the last laugh.
