I did as well until I read this rebuttal. As someone else said, I think we have so much riding on this we are all getting a little stir crazy and reading a little too deep into everything. IMO it is good news that increasing trial size was written into the trial design, although after reading Linda's rebuttal below I don't think that's the plan based on inside info.
NW BIO REFUTES FURTHER FALSE AND MISLEADING CLAIMS BY FEUERSTEIN
1 comment | Fri March 28, 2014 1:03 PM|PR Newswire | About: NWBO
BETHESDA, Md., March 28, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today refuted false and misleading claims by Adam Feuerstein in an article posted Thursday, March 27, after NW Bio's public presentation of significant positive news about all of the Company's programs.
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Feuerstein's headline falsely claims that NW Bio's CEO, Linda Powers, "disclosed problems" with the Company's Phase III clinical trial. On the contrary, Ms. Powers announced entirely positive news about the Company's Phase III trial as well as its other programs, and Ms. Powers emphasized in her presentation that prior claims by a commentator (i.e., Feuerstein) that there were problems with the Company's Phase III trial were unfounded and wrong. Ms. Powers reiterated that the Phase III trial is progressing well, and further centers of excellence are joining the trial.
The Company urges investors, analysts and other interested parties to view Ms. Powers' presentation (which is available via webex on the Company's website) to hear the correct, positive information and form their own opinions.
Feuerstein makes a series of false and misleading claims in his article. First, Feuerstein describes the Company's Phase III trial as "requiring a p value of 0.02 to reach statistical significance" and claims that this makes it more difficult for this trial to succeed. Feuerstein is factually wrong on both points: the Company's trial does not "require" a p value of 0.02 to reach statistical significance, and the Company's trial design increases, not decreases, the trial's ability to succeed.
The Company's Phase III trial, like all other trials, will be considered to reach statistical significance if it reaches a p value of 0.05. "P value" is a measure of the probability that trial results were due to chance, and not the result of the experimental treatment being tested. So, the lower the p value, the better it is. The p value generally required by regulators for statistical significance is 0.05.
The Company has created a significant cushion or buffer for achieving this p value of 0.05 by designing its trial to a level of 0.02 rather than designing to the exact 0.05 level. Having this cushion makes the Company's trial design more likely for the trial to succeed, not less likely as Feuerstein claims. If the trial were designed to aim just for a p value of 0.05 (as Feuerstein tries to argue would be better), there would be no cushion at all, the risk would be correspondingly higher, and it would be more difficult for the trial to achieve success.
A second false claim by Feuerstein in his article is a "guess" that the Company's Phase III trial has been "poorly run" and that the trial data "have been looked at some [sic] many times already that the 'alpha spend' has been gobbled up" -- meaning that unblinded reviews of the data have used up some of the statistical cushion. Feuerstein's "guess" is utterly baseless and is factually wrong again. There has been no such "alpha spend" to date. Further, the interim analyses in the Company's Phase III trial are structured so that there will never be large amounts of "alpha spend" in this trial.
Feuerstein further tries to claim that the Company's trial could originally have been considered statistically significant with a p value of 0.05 but somehow must now meet a totally different standard and reach a p value of 0.02 in order to be considered statistically significant. Once again, Feuerstein's claim is baseless and wrong. There has been no such change: the Company's trial design and target p value are the same now as they have been throughout the trial. The Company has consistently reported throughout the trial that it is designed to the 0.02 level. That is a major strength and an intentional trial design, as already explained not a weakness or the result of problems, as Feuerstein falsely asserts.
A third false claim by Feuerstein in his article is that if the Company makes a choice to increase the number of patients in the Phase III trial, the Company "will do so out of concern that the original enrollment figure (312 patients) is too small to produce a positive result," and that for the Company to exercise this choice (or even to have the possibility for this choice built into the Company's trial design) is something negative. Once again, Feuerstein is factually wrong. If the Company exercises its choice, the Company will be doing so on an entirely blinded basis. The Company will have no access to any accumulated trial data, and will not be acting out of such alleged "concern."
As Ms. Powers conveyed in her March 27 presentation (and prior presentations), the key to successful trials and regulatory approvals is strongly powered trial results. The Company has shaped it Phase III trial design in order to provide strong powering, reduce risks, and provide cushions. An increase in patient numbers is simply another way to enhance the cushion relating to the p value and thereby further reduce risks and make it easier for the trial to succeed.
"We can only conclude that Feuerstein and those with whom he is allied are disturbed by NW Bio's continued and increasing strong progress in all of its programs," commented Linda Powers, CEO of NW Bio. "We note that his attacks seem to regularly coincide with positive NW Bio news and with substantial short seller activity. Perhaps they are all just coincidences."
"Feuerstein's long history of false and unfounded attacks on NW Bio is directly contrary to the major validations we have received and continue to receive from leading medical institutions, and the most demanding regulatory agencies and health care authorities. We encourage investors, analysts and other interested parties to take a close look at these validations, compare them to Feuerstein's ongoing attacks, and form their own opinions about whom to believe."
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