I'm a little surprised at how well Delcath Systems
Maybe it's because no one noticed? I can't find a press release or an 8-K announcing the delay. The notice came during a conference call with analysts, but investors who failed to put it on their calendar when the call was announced last week would have missed it.
In February, Delcath announced that the Food and Drug Administration refused to accept the company's marketing application, citing multiple issues that needed to be cleared up. After meeting with the FDA, Delcath says it needs to submit hospitalization data for the patients from all the clinical trials. That request will take an additional three months to complete.
Whether the application gets resubmitted nine months or 12 months after the company originally submitted its application, isn't that big of a deal. But investors have to ask whether management should have known the data would be required and submitted it in the first place.
Combine that with the lack of easily accessible public disclosure, and I'm not getting a warm and fuzzy feeling when it comes to Delcath's management. Yes, other companies, even large ones like Roche and Gilead Sciences
Investors may be looking past the U.S. delay because Delcath said it's on its way to getting its system approved in Europe this quarter -- assuming, of course, that the European application is up to snuff.
An approval in Europe would certainly help regain credibility in my eyes. Until then, investors should check out straight-shooting companies like Salix Pharmaceuticals
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