Banker, he certainly has the right to his viewpoint. No doubt his investment didn't turn out like he thought it would (as has ours so far).
Two things come to mind. One is that the FDA appears to be permitting the company to go ahead with a pivotal trial, and now with a fast track designation.
Secondly, if the company can put together a deal with a significant pharmaceutical company with E-mab, then there is probably adequate evidence that it works, at least to the point of satisfying the FDA and a large company.
Amgen did not run the trial in a way that would prove the efficacy of CD22 one way or the other.
I spoke with a very highly regarded NHL Oncologist a few months ago and he told me that the patients used in the combo trial by Amgen would not have responded well to Rituxan alone (some were patients who had very short duration's to Rituxan already), and yet they responded well with the combo. It was his strong opinion that Epratuzumab works well in NHL, but a double blind, head to head with Rituxan is the only way to truly get data that proves it, and to what degree.
Dr. Goldenberg had a lupus trial ready to go in 2000 and Amgen decided not to supply product to it. It was about that time that Enbrel, the drug that Amgen paid over $10 billion for) was being looked at in lupus. That trial failed in 2002. Now Amgen has come out with another product that they would like to bring to the clinic for lupus. It is rather obvious that they had competing products for autoimmune and didn't want to take E-mab into that area. Dr. Goldenberg started his own lupus trial in Germany in the fall of 2003 and now, just over a year later, has fast track status for it here in the US. Maybe it works, maybe it doesn't, but certainly no oncologist knows. |
