Re: Ovarex.
Mark, I don't mean to be looking for dark clouds behind all the silver linings, but the wait has just begun. Really good news -- if it is ever to come -- is a long, long way off.
The data is said to show a "positive" (rather than "statistically" or "clinically" significant) response... and that 'positive' involved only a delay in tumor growth, not arrest or shrinkage. Moreover, it would seem the delay was only about twice as long as in the control group. This is not inconsiderable to the afflicted, to be sure, but much less impressive than other early-stage compounds have been able to achieve at comparable stages of the investigational new drug process.
Combined with the reality that Altarex still cannot describe with certainty why or how or by what specific biological mechanism Ovarex works, it seems to me that from the investor's perspective a key phrase in the company's press statement is, "These new data also strongly support our decision to conduct a third controlled but open label trial evaluating the relationship between dosing and these same parameters. The Company initiated enrollment in this trial in mid-September and expects to complete enrollment by February of next year."
Establishing the optimum dosage is no mean feat, especially when you aren't sure about the exact mechanism. It might well take more than one additional 'open label' trial and far longer than next February to learn enough to satisfy regulatory authorities so Altarex can proceed with some kind of double blind P-2 or P-3 trial. Once optimum dosage is decided, there is the need to revisit once again a host of other important issues -- preliminary efficacy, safety, side effects, etc. -- at that dosage level.
In short, one could say Alatrex has hardly begun the P-2 stage. It has a very lo-o-o-ng way to go and little cash to travel on before being ready to prepare and submit an FDA application for leave to proceed with a P-3 trial which itself would take years to complete, another year for analyzing results, and as long as an additional year before the FDA acts.
That said, there are grounds for hope -- if you're young enough and have loads of patience and money to see this thing through all the predictable stock dilutions and private placements. Unless, of course, the company manages to interest a big pharma sugar daddy.... |
