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Biotech Stock Mailbag: All You Need to Know About Hep C Drugs

If QS-21 turns into a big money maker, then pay Armen a salary based on a percentage of the adjuvant's sales. Perhaps he'd even deserve a bonus. But until that happens, don't pay the guy a dime. He's made millions of dollars already on the backs of his shareholders.


Jim S. writes, "Adam, by the way, Celldex Therapeutics (CLDX) put their CDX-011 breast cancer drug on clinical hold due to some issues at their supplier. They never issued a press release but stuck it in the 10-K. Kind of slimy."

Eh -- not such a big deal.

In January, FDA placed a partial clinical hold on Celldex's CDX-011 phase IIb breast cancer study because of manufacturing violations discovered during inspections at a third-party supplier of the drug. FDA told Celldex that no new patients could be treated with CDX-011, but patients already undergoing treatment could continue.

Importantly, Celldex completed enrollment in the phase IIb study in December, so the partial clinical hold doesn't have a significant effect on the company's ability to complete the study and release results at the American Society of Clinical Oncology (ASCO) annual meeting in June, per its original schedule.

We can argue about whether Celldex should have issued a press release about the CDX-011 clinical hold instead of just disclosing in its 10-K. As a journalist, I'm a "more disclosure is better" guy so I sympathize with the point made by Jim S. But this manufacturing problem seems like a relatively minor issue and has no bearing on the results of the CDX-011 study, which is the most material upcoming event for the company.

A Celldex spokesman said no press release on the partial clinical hold was issued because the ability of the company to complete the study and analyze results were not hampered in any way.

Celldex filed its 10-K containing the disclosure of the CDX-011 partial clinical hold on March 8, so it doesn't look like the stock was much affected. I've read some recent tweets from traders expressing concern about the fall in Celldex's stock price since late March. [The stock is about a buck off its high.] My take: This could be the unwinding of what's been a very successful pre-ASCO trade. If the results of the CDX-011 are positive in June, I expect the stock to rebound.

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