Replies to post #46995 on NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

One possibility is that DCVAX-L and DCVAX-Direct both get approved before the 90 day period, the stock price soars and no one really cares about the investigation results (other than perhaps when some of the hedge fund managers are arrested for stock manipulation).

Before you simply discount me as a pumper take a close look at the FDA guide lines on accelerated approval and tell me one can't see this being applied to Direct and perhaps even L too just from the Informational Arm results.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

Guidance for Industry
Expedited Programs for Serious
Conditions – Drugs and
Biologics

BREAKTHROUGH THERAPY DESIGNATION
Section 506(a) of the FD&C Act provides for designation of a drug as a breakthrough therapy
". . . if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious
or life-threatening disease or condition and preliminary clinical evidence indicates that the drug
may demonstrate substantial improvement over existing therapies on 1 or more clinically
significant endpoints, such as substantial treatment effects observed early in clinical
development."

Preliminary Clinical Evidence
Unlike the information that could support fast track designation, which could include theoretical
rationale, mechanistic rationale (based on nonclinical data), or evidence of nonclinical activity,
breakthrough therapy designation requires preliminary clinical evidence of a treatment effect that
may represent substantial improvement over available therapies for the treatment of a serious
condition. For purposes of breakthrough therapy designation, preliminary clinical evidence
means evidence that is sufficient to indicate that the drug may demonstrate substantial
improvement in effectiveness or safety over available therapies, but in most cases is not
sufficient to establish safety and effectiveness for purposes of approval. FDA expects that such
evidence generally would be derived from phase 1 or 2 trials. Nonclinical information could
support the clinical evidence of drug activity. In all cases, preliminary clinical evidence
demonstrating that the drug may represent a substantial improvement over available therapy
should involve a sufficient number of patients to be considered credible. However, FDA
recognizes that the data cannot be expected to be definitive at the time of designation.

Wouldn't you agree that the fear of this happening is much more plausible in explaining why we have seen such aggressive attacks of the company and manipulation of the stock. They are big time frightened of this happening and LP/NWBO completely alterating the playing field for fighting cancer with an extremely safe, but much harder to deliver personalized therapies. Big Pharma business model is for volume manufacturing of a single pill used for everyone.

Isn't this why all us longs invested to begin with. DCVAX is a game changer and of significant benefit for patients with really no other viable treatment options. It is really unheard of that the FDA would let NWBO used Direct with any type of solid inoperable tumor. They already recognize the potential.