I would love to see CLDX make and hold some solid gains. But I am prepared for the eventuality that everything will blow up. I am less confident in CLDX than I was in PCYC in its early-phase days.
I didn't say that node status should be or has been ignored. I gave one reason for NLNK's failure to disclose any info on it. If they know and are withholding, I would be even more inclined to think the trial will fail.
People will debate the significance of the 6-month requirement. No one can know a priori how long any patient will survive, regardless of prognosis based on stage. The median survival of most resected patients appears to be more than 6 months (which I mentioned but you ignored; you've decided that the 6 months is critical, and that's fine, though you can't/don't articulate why other than to point to other studies that don't have that requirement).
I believe it makes sense to ensure that enrolled patients be healthy enough to receive the mandated treatment (especially chemo followed by chemorads). If stage and prognosis are evenly distributed through both arms, it should be a non-issue. Yes, it's obvious that healthy, good-prognosis patients SHOULD live longer, but if algenpantucel is truly effective, the experimental arm will still eventually show a statistically-significant benefit.
I think you're splitting hairs. Who asked the DSMC to conduct the review? NWBO, apparently in response to shareholder inquiries. So the stimulus to conduct the review was shareholder inquiries.
The six-month survival requirement is a non-issue, and meant to weed out patients with comorbidities which could influence outcomes. Depending on whose data you look at, even patients with node-positive disease are expected to have a median survival of 10 months or so (the range would be 2.5 months to 30 months, approximately). SEER and the NCDB suggest that 40-50% of patients with regional nodal disease are expected to survive one year.
I agree that it's concerning that NLNK hasn't divulged any information about outcomes and their relationship to node status, etc., in phase 2, but the numbers may be too small to make any kind of useful interpretation.
I still think that the more likely outcome of the trial is failure to meet the primary endpoint.
Yes, but it's no secret that plans can be structured around future news. Insiders can then sell into the runup to those events.
I find it odd that a DSMC would do anything "in response to shareholder inquiries" about a trial. They're supposed to be independent, and therefore unswayed by outside opinion or pressure. If they're independent of the company, why are they not independent of shareholders? Unsettling.
Anyway, the odds were heavily against the success of DCVax-L to begin with. These new developments don't make me believe the odds have improved.
That would be great, although there are greater odds that the trial will fail and the pps will take a minimum 70% haircut.
Might be. Analogous to blocking PD-1 vs PD-L1. Could be similarly effective strategies, could be different.
"Weakness" doesn't quite capture what's happening to this stock. It's getting mauled. Off 20 points from its high and getting close to free fall.
It's doing about as badly as a pps can do without actually having negative trial results.
You're trying to talk sense into someone who thinks he can control the movement of stock prices.
His hatred is deeply ingrained, the product of a poor education and worse breeding. Maybe he's forgotten his his ancestors were (and still are) denigrated and ridiculed when they first arrived.
No. All it means is that the experimental arm is no worse than the control. It is still possible that the experimental therapy will prove to be ineffective.