The problem was with PFS with STS --- a very difficult cancer to stop progression. They should of worked with the FDA to establish a "Non-Inferiority" Primary Objective along with Safety.
The first trial and this trial do NOT correspond ... so I am seriously questioning the integrity of the first trial.
It flat out failed as it was identical to doxo --- so the higher doxo obviously doesn't help with STS.
Now this still has Lung and Glioblastoma trials, but also they did for one positive have double the "Clinical Benefit" up to this point, but the question is if they didn't have the amount of information they were supposed to, why not just wait till they did?
I guess this was Enough to determine that Aldox just didn't add much benefit if any other than the responses.
Once again: the first trial and this one do not correlate at all. The first was 6 months to 3.3 months which sure doesn't make sense here.
The overall response rate or Tumor Reduction was nearly Double...so this could be a pathway to approval, but it should of been stated in the Primary Objective measurement. So the tumor Shrinkage was more in the Aldox group, but progression was unchanged vs soc.
Also: Stable Disease of 4 months or more was double, but the fact that Median Progression was not is concerning, but they didn't give that much info on exactly how many were measured for sure, so the follow up will tell a lot more about Aldox.
That said: I would of thought the PFS would have been longer --- BUT in STS I am NOT sure that this is the wisest choice to make because these tumors progress rapidly don't matter what when treated previously.
DCR was also stat sig in the Aldox --- more partial responses and stable disease ... .0415 and this number should be lower at the next assessment.
50% of the patients were excluded from PFS assessment --- that said --- once again still doesn't correlate with the first trial. Just doesn't make much sense
This was Plenty of data to confirm that PFS is a FAIL. The ONLY path is if they follow all the way through for OS which will be 2017 at Earliest if not 2018.
Just hope that Lung cancer is better. This will be a disaster for quite some time.
Definitely could be right on this one. As much as I was hoping that CERU would come out on top, the control just may be a surprise.
The price drop from 4.30 to 2.00 tells us that the confidence level in this stock is not high.
I still believe this company has potential to become a good one, but it's too early to tell right now.
As all biotechs --- this one is a gamble also.
The technology appears very interesting but the set back of the trial more often than not is a negative which the price is reflecting.