Too much FUDs from long today, and it seems most short takes a break. What a coincident?
For God's sake, if holding a few tens of thousand shares or a few hundreds of thousands of shares make you sleepless, sell enough before TLD if that makes you sleep better;
And the thinking of "but what are the chances our placebo group did better than expected," from a long, please give me a break!
In other trials with other indications, this had indeed happened repeatedly. To the knowledge of the SOC treatment for GBM and its outcomes, and the outcomes of numerous of clinical trials of various agents for GBM, none has indicated placebo (SOC) has had better outcome than the treatment, only exception I saw is with the result of CLDX Phase 3 trial. Nonetheless, in the trial, its placebo is not actually placebo and instead a proven active agent called KLH. In the case of NWBO, the placebo used is autologous PBMC which is known to be inactive substance compared to KLH.
Now what matters is that nwbo has run a lengthy trial and had five years of trial data for all patients, and as of 5 Oct, the trial has been locked for analyses.
What we have known are 1) its primary endpoint will be met, and it's highly likely at least some of its five other secondary endpoints will be met as well, which is enough for FDA approval.
Nobody in FDA in his/her right mind would not agree the above, particularly if more than triple or quadruple of patients in the trial can live five years than SOC patients!
EU approval is guaranteed with approved adapted endpoints, which at least warrants a price of $2-3 now; USA will follow. Even if FDA has not yet bought in with the adapted endpoints, it will be forced to approve with the convincing data.
We are all living in the public eye. FDA's own ADCOM if called upon will deal a huge blow to FDA, and FDA will have a convenient excuse to compromise -- agree to approve (this is of course a speculated worst case. I personally believe FDA like its EU counterpart has bought in the adapted endpoints. No reason why not.
Before the huge running up beginning a month ago, I said buying anything below $1 was no brainier; now I say buying anything below $2 is no brainier.
Facing TLD any day now, manipulation can only have a very short span of life.
Have to run for some errant. No time to spell check, or edit. Sorry for any inconvenience
