10.20.11 | Brandon Glenn

Neoprobe: Hedge fund critic still predicts FDA rejection of drug

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.)

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.

“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.

Brandon Glenn MedCity News

Brandon Glenn is the Ohio bureau chief for MedCity News.

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Tags: Cancer, NEOP, Neoprobe, Ohio, pharmaceuticals, publics

Comments Post a comment

Shkreli exemplifies the mo of a pathological fibber. he did indeed write the nda for “SEEK” would not be accepted via his back and forth w/readers post his sa article. he is a cowardly empty calorie and since he mentioned he was a father his children are the worse for it.

Comment by Palantir — October 20, 2011 @ 1:06 pm

Shkreli seems to be on the wrong side on several counts. He has no significant medical experience and pushes his views without credible evidence. It is quite clear that LYMPOSEEK offers a safer (no deaths) and more accurate results than current drugs.
Martin prefers to continue has position seemingly based on his misguided short position.

Comment by J Mulvo — October 20, 2011 @ 1:42 pm

That’s correct per my memory too. He did state that the NDA would not be Accepted via his back and forth comments w/readers with the SA Article/Blog. He’s fibbing about that statement. He obviously did not think the NDA would or should be Accepted by the FDA since he completed a CP. Why else would be complete the CP. That’s why he defended and argued with the readers and posters and stated it wouldn’t be Accepted. Otherwise he’d had to admit that he completed the CP to cause concern and controversy and to manipulate the stock which would be the other reason to complete the CP. Put he stated he was a concerned citizen and felt it needed to be pointed out to the FDA and they would then reject the NDA. It was not because he was attempting to manipulate the stock due to his short position, he was being a good citizen and the FDA would, per him, reject the NDA due to the reasons he shared in the CP and via the articles/blogs.

Comment by Shorts Lose — October 20, 2011 @ 1:53 pm

Ha! Ha! Shkreli being a good citizen and that’s why he completed and submitted the CP. No, he was shorting the stock and needed to drive the price down, hence, create doubt was the reason. Hence, he had to state that he felt and thought the NDA would be rejected and he did that on his posts to other readers of the SA article.

Comment by Shorts Lose — October 20, 2011 @ 1:58 pm

“I’ve been searching for quotes from Shkreli that would contradict this assertion, but haven’t found any.”

Brandon:did you search include Marty`s back and forth on his blog and more importantly his written responses after his sa article(s)?

“That’s correct per my memory too. He did state that the NDA would not be Accepted via his back and forth comments w/readers with the SA Article/Blog”. per SHORTS LOSE.

Comment by Palantir — October 21, 2011 @ 10:46 am

The FDA and NCS are a bunch of back stabbing crooks that make too much money off of treating Cancer. They don’t want a cure unless they can make a profit. They steel research and the claim it as theirs. Then they squash any one that tries to disagree. We are the blind sheep that are being brainwashed that the FDA and NCS are working in our best intrest. They work for profit only..

Comment by Dave — October 21, 2011 @ 11:25 am

I’ve reviewed the comments section of Shkreli’s Seeking Alpha posts on NEOP and still can’t find evidence of him predicting that the FDA wouldn’t ACCEPT the Lymphoseek NDA. But that doesn’t mean he never said it. If you can find an example, please post it in the comments here and be sure to include a link. Thank you.

Comment by Brandon Glenn — October 21, 2011 @ 11:46 am