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akasidney86

03/17/15 4:57 PM

#30955 RE: Pyrrhonian #30939

Again, I think he meant what I said; that a trial that doesn't meet RECIST CR standards but DOES create a significant and durable OS response will not be considered a failed trial by either the FDA or the market... NOT that the FDA will figure out some new way to approve the drug on that trial's results and the market will value it as such. To your questions and the proposition that the market and the FDA view and/or value a failed trial equal to a trial that shows significant OS improvement is, as I said, absurd. Failed trials have a value of $0 to the market, and are of only historical and informational value to the FDA. The alternatives, successful trials, even modestly so, clearly do not.

To consider the argument, let's take a look at our very own NWBO. I stated, back when MDA published it's "there's an effect" SITC study, that while it wouldn't ignite the value, it would build a floor under it... and that's exactly what happened. Not only did it not drop from there in any real way (8%), but is now up, even with the past two day drop, about 40% from then. Now, you can say that that happened because the moon was in Gemini, but that's what I would call the market valuing drug effect in a clinical trial. Obviously, had the same MDA study presented then said "there's NO effect seen", the outcome would more likely have been a 50% plus DROP in value, not a 40% increase... regardless of where the Moon was.

Beyond that, the FDA will, of course, approve on an OS endpoint against a control group, so if that is shown, both the FDA and the market will revalue... upwards, in a very serious way. The way that happens is that in prior trials a significant OS benefit is shown against historical norms, and that can lead to a blinded OS trial. In short, I don't see any way you can argue that proven increased survival against historical norms will be seen as valueless to either the market or the FDA. It may not set the world on fire, and just with historic comparison will certainly not be approved or even presented... but nobody's just going to just shrug and move on.

Well, let me rephrase. You may. I won't.
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Dan88

03/17/15 5:19 PM

#30957 RE: Pyrrhonian #30939

I think you still don't get it on how market would react in general on a small biotech company's stock. In my 25 years of experience in trading (or investing, each 50% of the times)small cap biotech companies, nothing is important than perception, not your perception, my perception, nor any retail investor's perception, but the perception of one or two big investment houses (funds).

Of course, fundamentals are important; TA is important, catalysts are important; binary events are important, financing is important, you name it.

Still,if one wants to time and sense how high or low the stock can go, pay attention to institutional interests. I have said recently and I would like to say again that the dynamics has changed in the case of nwbo since Woodford was onboard.

How high can nwbo's stock can go? Juno, kite, blue and cldx all can serve as example with equal market cap; how low can it go? imuc may come to mind if DCVax fails.

BTW, congratulations on your selling at $7.5 one or two weeks ago and buying some put on friday, but, young man, we have a lot of things to learn.