Replies to post #66955 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Great video RK… when you listen to it, it’s as if Dr. Hodi is speaking directly to our experience with DCVax-Direct. I’ve transcribed the relevant section below.

Video link RK found:

http://www.dana-farber.org/Research/SIDTALKS/How-Our-Body-s-Own-Immune-System-Can-Be-Tapped-to-Fight-Cancer.aspx

4.25 min mark

What we found is that sometimes on the CAT scans, the tumors got bigger before they got smaller. Or that things didn’t change much, and then all of a sudden would start responding… weeks, months, sometimes even years later.

And so this kinda stopped our drug development, or slowed down our drug development for awhile ‘cause people were saying (certainly investors who aren’t invested in NWBO) you’re not getting responses, this isn’t really working. Companies are like oh their response rate isn’t that great, we’re not going to invest millions of dollars to get these drugs approved. But what we found out is that when we biopsied these tumors after treatment, there was very little cancer cells there. It was filled with immune cells, T-cells, that had gone into the tumor, were destroying the tumor cells; and by a CAT scan, you can’t tell the difference between what is growing tumor or what are immune cells, and what’s going on in the tumor environment.

This kind of paradigm allowed us to understand that sometimes the treatment could take time to work, and even if things weren’t shrinking, that you could still get a long term benefit.

Think about how many times and in how many ways those who are not invested told us that Direct had had no effect. And yet, when you listen to this presentation, it is exactly what Linda and Dr. Bosch were telling us about the response tumors were having with Direct in it's P1.

Yet no matter what proof the company presented, it was rejected by those who were not invested. They insisted that there was an immunological effect going on in with those tumors.

And yet we can view here in Dr. F. Stephen Hodi’s presentation, that what NWBO was finding in the summer and fall of 2014 marries up to what Dr. Hodi says in his discussion in November 2014 (the date of this presentation - http://www.dana-farber.org/Research/SIDTALKS.aspx).

Maybe I should send the link to this video to Daniel Sommers, the lead attorney for Chad Lerner, and the other two lead plaintiffs… because these lawyers and their clients still think the tumor necrosis in the Direct trial was due to needle trauma, and not the effects of treatment. Of course, they also present that Dr. Buzdar was the lead DCVax-Direct trial investigator too (no mention of Dr. Subbiah is made); and unbelievably, Dr. Buzdar’s interview with AF makes up a great deal of the plaintiffs’ case.

See below for direct statements lifted from the Memorandum of Law in Opposition to Defendants’ Motion to Dismiss dated 6/13/16.

These misrepresentations were so egregious that trial investigator Dr. Aman Buzdar took the highly unusual step of publicly admonishing the Defendants.

Dr. Buzdar also confirmed that the tumor necrosis effect claimed by Defendants meant nothing because repeated studies demonstrate that needle trauma causes such necrosis whether or not the delivered liquid has any therapeutic effect. Id. Thus, it was “a tremendous leap to say that this is a real response, which is why what the company is saying is so inappropriate.’”

Defendants: (a) omitted that trial investigators had not even reviewed the data they claimed to show effects and responses; (b) falsely claimed “local and systemic effects” without any scientific evidence to support that claim; and (c) omitted that they had no evidence linking tumor necrosis to any treatment effect, rather than mere needle trauma.

Plaintiffs base their allegations regarding the falsity of Defendants’ DCVax-Direct press releases not on conjecture, but on the statements of Defendants’ own clinical investigator

Defendants cannot dispute that Dr. Buzdar’s conclusions were plausible, and cite no case where the concessions of a drug company’s own clinical trial investigator were insufficient to establish a reasonable belief of falsity.

For example, Defendants ask the Court to discredit as a matter of law Dr. Buzdar’s admission that tumor necrosis was likely due to needle trauma rather than “effects of treatment.” This is clearly a jury issue.

…that the Company had a propensity to report only good results, while not reporting bad results, according to the clinical trial investigator charged with overseeing the other NW Bio clinical trial for DCVax-Direct.

To observe Defendants’ recklessness regarding DCVax-Direct misrepresentations, this Court need only look to the neutral evaluation of Dr. Buzdar, investigator for the DCVax-Direct trial.

…after the DCVax-Direct trial investigator, Dr. Buzdar, partially disclosed Defendants’ misrepresentations in a statement he provided to TheStreet.com

It is truly unbelievable to read that the plaintiffs are claiming Buzdar was the DCVax-Direct clinical trial investigator at MD Anderson.

You know they know he isn't, but presenting him as if he was is littered throughout this court document. It's actually filled with quite a bit of other litter too.

Anyhow, thanks for the link RK. :)

[iclight]

Of course he will speak about the combination approach because he knows the singular approach (the Phase 3) doesn't work.

[Know-Fear]

Good stuff. Thanks.