The two major criticisms of CLDX coming from seasoned biotech investors is that CLDX doesn't have a good assay for GPNMB expression (011 breast cancer trial) and that CLDX is moving up many lines of therapy for the Phase III, which is not justified by the Phase II's. I've just learned from my sources that CLDX is working on a much-refined assay for GPNMB. The second criticism I personally don't believe is valid. If 011 works in breast cancer, I think it has a good chance of out-perfoming Xeloda, the comparator arm. Yes, the trial is more risky (and there is no SPA), but moving up to front-line therapy potentially carries with it huge rewards.
If the GPNMB assay is a biopsy DNA/RNA test, then CLDX is set. The Supreme Court's decision on intellectual property and DNA makes a lot of these assays easier to develop/license/obtain for companies like CLDX.
That is absurd. Phase IIb demonstrated high GPNMB in TNMB to have 34% PFS vs zero in the IC arm (which included everything under the sun). Also HIgh GPNMB alone demonstrated more than a 2 to 1 statistical difference in PFS
These criticisms come from biotech investment newsletters from reputable people. I think it's always good to look at my investments from all sides. And, frankly, shorts tend to be smarter than longs.. But the bear case on CLDX is not convincing, IMO. Furthermore, the bears underestimate the value of CDX-1135 and especially that of CDX-1127. If CDX-1127 results are positive, even in early-stage trials, and if the Market perception is that CDX-1127 can be usefully combined with the PD-1 inhibitors, then the sky is the limit for CLDX.