Replies to post #389246 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

No, the redefinition is not driven by NWBO, and happened before unblinding anyway. So that would certainly be consistent with the AF’s allegations but it is factually incorrect. Factually incorrect allegations, even if made just to make noise, are still incorrect and will have no impact on the FDA’s decision making.

Basically the FDA would not take note of such noise. It’s not relevant to the historical record, the science or the facts. NWBO does not drive the WHO’s or the oncology community’s definitions of specific cancers and in fact, getting the data prior to data lock was likely hugely difficult, costly and inconvenient for the company, so that it could follow the scientific community’s updated view. As to NWBO, that view could have gone any way. It just happens to be favorable to the company. They did not make it so, the science made it so.

[VikingInvest]

reclassification or not, people are living longer and FDA can ill afford to get caught up in these definitions.

[anders2211]

You are misinterpreting the meaning of Ad hoc analysis and data mining in biotech data analysis. Ad hoc data mining in biotech means asking a new or rephrased question after the data has been unblinded to the investigator to suit the unblinded data better.

Now that the independent WHO has rephrased what exactly GBM is, certain data points in the DCVAX trial can be excluded which does not change the questions, endpoints as were asked before the data was lock in the SAP.

How many yellow M&M's are in there in my 100 MM's with colors blue, green, orange, and yellow? Answer 25 of 100 = 25%

Ooh blue MMs are no longer MM's says the God of chocolate, out with 10 blue MM's ok now its 25 of 90 = 28% that's a 12% improvement of yellow MM's

[biosectinvestor]

You said, for instance, in one of many posts:

“the reclassification by WHO, just gave NWBO another possible ad hoc set of calculations to see if they would work.

In other words, the fact that this new classification had the blessing of WHO, and is mot merely the result of NWBO data mining, does not make the new calculation ant less ad hoc.”

Excuse… you said NWBO now has an excuse to take an ad hoc approach, that implicitly makes this some bogus thing that NWBO is doing. Those are not my words, that is the general gist of your statement.

I merely said that it’s not an excuse, effectively, they MUST respond and have an answer to the redefinition because it is the regulators job to ask about this and it is their job to have answers. Period. It’s not a tactic, it’s not some excuse to take an ad hoc or post hoc analysis. It is necessary to get the license to treat the condition that has now been redefined by everyone else, including the regulator, who will certainly ask about this issue, it is not some irrelevant new thing they are bringing in because it helps them. It is not some tangent, and it is not inexplicably damaging for them to ensure they have the data and the answer to a question they know will be highly pertinent to the regulator, even though it actually happens to help them.

Turning random changes or even good things into bad things is one of those things that happens on bulletin boards. Unfortunately. People worry a lot, I guess.