For the record, I'm long Vical, but I'm a nervous long.
AF's thesis is that A-7's phase II patients were significantly healthier than "average" StageIII/IV metastatic melanoma patients, and therefore its 19 month survival results aren't meaningful. I'm beginning to wonder if he might have a valid point.
Recent description of A-7's phase II:
It says patients were M1a or M1b (not M1c). This paper:
says M1a patients have median survival ~7 months, M1b have MS of ~17 months. It also shows that patients with normal LDH levels have MS around 5 months longer than elevated LDH patients. And we know the A-7 patients had normal LDH.
So if A-7 had more M1b patients than M1a patients, that might push MS up to 14 months. The normal LDH adjustment would push that up to 19 months, and there you go, A-7 had no effect.
I'm not saying that's what happened in phase II. But is it unreasonable to think that it might have happened? (I know that this is a separate question from what's happening in phase III)
> Where does that put Feurstein?
My inclination is "village idiot" but I don't think he is an idiot, despite his impressive Lack of knowledge. I think he is a garden variety knucklehead who is paid to take a stance that his buyer provides. Not much thinking involved, good or bad. Given that, I do find it shocking that people actually trade on his nonsensical commentary.
What I'm hoping for here is something like:
--Actually Tek, your facts are right, but your logic is wrong because of [?]
--Good question, but it turns out those facts don't apply to the A-7 phase II because [?]
--Yes, you might be right about that.
I'm plenty skeptical of AF. I'm just trying to get some clarity on that phase II trial.
Thanks in advance.
In the small trial you cited, the patients treated with DTIC having characteristics similar to those in the VICL trial still have a median survival below 12 months. So while it is possible for the DTIC control to do better than the 11 months originally predicted by VICL, there are no studies including the one you cited to lead anyone to suspect that the control group will live so long as to threaten the superiority of Allovectin. The current delay in the trial would be explained by a control group median survival of 15 to 18 months and Allovectin arm having a median survival of 32 months. Giving the control group a median survival of 15 to 18 months exceeds all past resutls in any trial including the one you cited and still Allovectin wins hands down. Moreover, AF does not consider safety which is a big plus for Allovectin with no grade 3 or grade 4 side effects as compared to 25% to 45% for DTIC.
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AF has a nice gig going. He can be 100% negative and be right over 90% of the time. It is just the reality of drug trials.
When a candidate he bashes does succeed: 'oh well, I was wrong about that one'.
Only 3 things matter in analyzing these companies: management, money and technology. If you trust the first and they have enough of the second you are looking at about a 1 in 10 success rate. A bit better if management is very good and they have a nice pile of dough to work with.
AF, or any other commentator for that matter, is no better at reading tea leaves than the corner gypsy.
Really excellent point, kih9, most people do not realize what extreme longshots biotechs are. Just say, "It won't work" and be right 95% of the time. That's why the payoff is so huge when that rare one does work.
This was a comparatively small study with only 13 M1a and 32 M1b subjects and only 21 of them receiving only DTIC which was the phase 3 A-7 control arm treatment. I wouldn't put much stock in the results of 21 subjects.
I thought he did not have a point becaue others have said that the phase II had sicker patients while the phase III had healthier. but one poster and supporter said that feurstein was correct, with certain cobnditions still in vical's favor.
I too am nervous. nearly a year ago it was said that we would have an answer by the end of last year. there have been several delays, and we are lucky if we have an answer by the end of the year. However, the optimist in me is believing that the fda is being very careful here because this would be vical's first approval, and this is a unique platform, and they want to be careful for this reason and to set protocol for future products with this platform.
Again, this is the optimist in me.