The company originally thought they would hit the targeted event rate in Sept-Oct 2011. That was based on a model where the control group had a median survival of 10-11 months and the Allovectin arm had a median survival of 18-19 months. Then the company thought we would reach the event rate in June 2012 as patients were living longer than expected. In xonjunction with Chippers model and my inputs we formulated possible results that would conform with a target event rate in June 2012. That model had the control arm with a median survival of 15 months and the Allovectin arm with a median survival of 25 months. Now, it appears that the targeted event rate won't be reached until fourth quarter of 2012. That would probably be explained by a model that had the control group having median survival of 15-18 months but the Allovectin arm having a median survival of at least 28 months and possibly well over 30 months. Such a result would be a tremendous advancement in the treatment of melanoma. We need patience, but we may have found the biggest victory so far in the war against melanoma.
Absolutely agree. At this point the residual survivors will die at a much slower rate. Even with untreated metastatic melanoma their are long term survivors. My biggest concern is that vical may have a suspicion that the results are marginal at this point and are fearful that early results will not have the statistical power to show a difference. I really do not think that waiting will have a substantial effect at this point. The death rate at this point is not a linear progression. With each month that passes the rate that the people die will cont to decline(second derivative of the absolute event). The other reason for dealing results which may be the most plausible reason for the delay is that more pts dropped from the trial than expected and the only way to achieve an increased statistical power is to increase length of the trial. All of which makes me less enthusiastic.
Can VICL share the primary endpoint with the Public, then provide the number of events when the target is met at a later date. Does VICL has to wait for the priomary and secondary endpoints to be met before the data is shared.
On the other hand, I can see that both endpoints need to be completed before a request to FDA be submitted for approval.
A separate point, I still don't see that there is a connection with the latest share offering with the delay of events.
Thanks for all constructive comments.
What else could it possibly mean except that it is working? The question is, if it is so obvious, why isn't the market reacting? Is there another possible explanation for the delay? If not, I don't get it.
In the absence of absolute facts on this matter, there are other possibilities of course. With the premise that the events (death) have not reached 50% for BOTH arms, the following possibilities can be generated and one can take his own pick:
1. Control arm has reached the 50%, but A-7 arm hasn't
2. A-7 arm has reached to 50%, but the control arm hasn't
3. Neither arm has reached to the 50%, so the trials will continue
Based on historical research data, number 2 may not be probable, so the other two possibilities exist. Regardless, most patients are obviously benefiting from this trial and this is a good thing.
I won't pay too much attention to the few cents down in pre-market. I think some are feeling tired of waiting for a more definitive result.
Couldn't another explanation be that everyone is living much longer (including control patients) due to the fact that this trial started with healthier subjects? I hope that's not the case but it seems possible.
The company's model has failed to give reasonable prediction of the time table.
So we do not know what they are looking for and what is the base at this time.
Company must give more specifics to comfort investor making a right decision.
What they may end up proving, what we all may learn, is that for a small subset (c.12%) of the Stage III and IV metastatic melanoma patients with the Heath markers used by Vical to select candidates for the trial there is a much longer than believed survival period. Note; I am a Long.
(I am Self Bumping this post of 18 months ago not because I am seeking, as would be the case in most self bumps, to bolster my credibility which lies in tatters due to my evident long term, significant to me investment and subsequent losses, but to provide to those who care about such things a short, to-the-point answer concerning What Happened?)