Replies to post #273072 on NorthWest Biotherapeutics Inc (NWBO)

[vator]

I would say they were a bit subjective with NVCR. New rules should be based on historic results. The idea is to make the patient outcome better. How is it better if comparisons to chemotherapy markers are the goal and not the chance of a longer and more productive life.

[Extremist223]

Its not magic fairy dust. Its not a random subgroup, its tcells and genetic signature. Sequencing is standard of care 2020 lets go.

[Doc logic]

manibiotech,

The rules in force now are indeed objective. The problem is that decisions to move beyond the rules to take into account other aspects are subjective and those are the standards that Linda is seeking to make objective. You have companies that fail to meet their stated objective goals with a product but some products get accepted for use anyway even in situations that make use more harmful based on subjective application of the rules because other measures are considered important. Linda is saying to FDA that those measures should not be selectively applied but rather objectively applied based on the importance of maintaining safety first and correctly identifying who will benefit even when a broad net is cast and not every fish is caught. She is stating the obvious when she says that time, which many patients don't have much of, and cost to develop drugs can be greatly reduced by approving drugs for the patients that a treatment works for or helps other drugs work for the first time around. This concept is just not that hard to understand. Best wishes.