Many investors do not accept historical controls as proof of concept that a drug works.
True, which is why only SOME investors are able to get in on the ground floor.
Unfortunately, while the FDA gets thru its lawyering of a given new drug, many patients are dying, even though the best specialists (oncologists at premier institutions) KNOW that the drug works, based on their sophisticated KB and medical intuitions.
I think it's a very good investment strategy to look to the thought leaders in the trenches, and invest based on their assessments, even if there is no control arm.
the lack of control arms in the trials completed to date is utterly germane to the valuation of the stock
True, which is why you can still buy ADXS in the sixes! What is "utterly germane" to me is the reasonable expectation of success, based on "proof of concept" as it is at this time!
We know that the general approach of identifying specific tumor antigens is creating tremendous excitement in the medical community AND that Advaxis' delivery platform has shown its efficacy. Enough "proof of concept" for me.
DD, what would be the reasoning by not including a control arm? Cost? Time? Delaying the length of time it takes for investors to find out the drug isn't efficacious?
This might be a good reason that I hadn't thought of yet for why the market just doesn't seem all that interested in ADXS (comparatively speaking). Any insight is appreciated.
Dew I'm sure ADXS doesn't know what to do about there trials. Pretty sure they have included the FDA in on all that there doing. ADXS is probably flying blind spending the big boys money and just guessing on what trials the FDA wants them to run? Seriously? Do your DD on what and who set up trial designs? Not hard to figure out why and who helped them get the trials going. Placebo group will take longer but results on AXAL have been quite thoroughly talked about and given certain trial criteria to put them on a fast track approval. We are closer than most here know. Our technology is getting more and more peer reviewed as trials go on! Amgen will be the ones taking us out it's not if it's when!