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Re: chinatown1980 post# 168865

Friday, 04/20/2018 4:17:45 PM

Friday, April 20, 2018 4:17:45 PM

Post# of 701760
You keep coming back to their decision to not unblind the trial early. LP somewhat explained her reasoning for this at the ASM. I don't think the long tail is a very good excuse (because long term data can keep coming in); however, I'm on the outside looking in. I do think IMUC was holding up a letter in years past saying PFS was not enough, and until Avastin was just FULLY approved for rGBM a few months ago on PFS as a SECONDARY ENDPOINT, I don't think PFS (if it was successful earlier) would have been enough. I think it is now -- if it is successful, based on the Avastin precedent. So here we are. The trial should be unblinded soon, IMO. Should be. I don't buy the long tail justification as a sufficient excuse to keep the topline results from being published. What we now actually seemed learn is that Fraunhofer thinks the trial would not get analyzed until the last (living) enrolled patient in Germany received their last dose.

That actually seems to jive with something LP was saying way back in 2012, but in between, it seems they thought they could unblind sooner than that. Alas (....time. Don't think twice, it's alright), we seem to be back to her 2012 premonition, if you will. Two full data sets from either side of the Atlantic, from two different manufacturing sites, which in theory, will both be used together, as a package, to support marketing applications, first in the U.S., and next on the other side of the pond.

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