Replies to post #231348 on NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Evanstory,

I don’t think you and I are talking about the same risk at all. You seem to be talking about management’s financial risk where as I am talking about regulatory risk and corporate compliance risk, not money although that is a downstream result of such risk.

MI Dendream
Quote:
That the show you saw two days ago was not even remotely close to the risk that was assumed by management


you are not talking about the risk assumed by management... you are complaining about management not meeting your risk expectations... I know you have a different perspective, but that is the way you are coming across to me...

your association with the "ASCO risk" is nonsensical to me... just saying the way you come across to me...

management has IMO risked far more than any shareholder... to some they say the wages have been really good for management to me the risk of failure for management is far outweighed by the salaries they have taken... more like earned!

Let me explain a little further to add to broader comprehension. First, it is important to understand that the guidance issued by FDA updating a companies ability to market beyond that which is specifically incorporated into the label remains draft guidance at this time. What that translates to is that companies who dare are able to market data from trials that uphold high scientific standards of randomize and blinded or are part of the package that contributed to the ultimate approval of the product. This also means that this draft guidance only applies to drugs that are approved in the United States however enforcement extends around the globe. This ultimately means To me it isthat companies may dip their toe in now and FDA will evaluate the result before deciding on long term policy.

Second, it has been very clearly stated and very clearly enforced to the tune of multiple billions of dollars in restitution that any communication from a company outside the Safeharbor of scientific discourse and or research related education is marketing. Period, End of discussion. If you do not agree with this point then there is no purpose in discussing this with you anymore.

Third, any person in employ of a company whether full-time, part-time or limited third-party vendor such as a CRO or a primary investigating physician Is considered commercial outside of Safe Harbor. This too is not up for debate. Again if you disagree, I am done communicating with you whoever you are. While medical, R&D, drug safety staff etc. object to this position and frequently ignore it, they have been the subject of many a warning letter And or settlement. Traditionally FDA And OIG have been lax in enforcement of companies that have only assets in phase 2 or earlier development. Traditionally as well FDA has been very hard on companies actions during any part of the review process. On this next point you may disagree, but it is my belief that Northwest biotherapeutics has been in the midst of a regulatory process since late July or early August 2015 and this has been A contributing factor why their lips have been sealed as far as the Halt is concerned.

During ASCO It is a critical distinction that they presented from the commercial booth. I believe their new language including a caveat that this material was not endorsed or approved by ASCO was communicated with ASCO leadership in mind. This is an interpretation of tone and language by me.

FDA has long been very clear of this distinction and chooses oncology to enforce this more frequently than any other field. Do your own due diligence if you do not believe me.

It is a belief among many in this field that FDA does in fact hold grudges and penalizes companies that blatantly violate their interpretation of federal law, even when they have lost in the Supreme Court. Premarket promotion is one of these Sacred Cows. The typical penalty that has been speculated is delay in drug approval through Approvable letters because they have lost multiple times against patients and industry regarding free speech restrictions and avoid public battles now. This is all popular speculation and not an accusation. None the less, it represents risk in many, many ways.