Delcath Systems Inc (DCTH)

[manny t]

DCTH,

"The reality is that this product met its SPA, will get FDA approval on a single trial, and will be widely adopted for those patients with this condition – melanoma spread to the liver."


http://www.andrewtobias.com/

They presented their data over the weekend. At these presentations, there is an independent reviewer who gives his opinion of the data. On the plus side, the data on the primary endpoint – progression of the melanoma in the liver – was better than expected and there was a statistically significant benefit in delaying progression overall. Also, statistically significant difference in response rate. There was no difference in survival – because they allowed half the patients to cross over [from the placebo]. If you compare survival for those who didn't cross over to those who did, there was a doubling in survival – but the numbers were so small it didn't reach statistical significance. There were also a couple of patients in the treated arm who died very soon after the treatment – none was actually caused by the procedure, but because they happened so rapidly, they had to be counted as "treatment related." Because of this survival data – and the trial was not designed to show a survival benefit – the independent reviewer said the didn't see that DCTH was providing any benefit. That is why the stock was down so much.

The reality is that this product met its SPA, will get FDA approval on a single trial, and will be widely adopted for those patients with this condition – melanoma spread to the liver.