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Re: skitahoe post# 690893

Sunday, 05/12/2024 8:04:55 PM

Sunday, May 12, 2024 8:04:55 PM

Post# of 694220

it could easily take a decade or longer,


While that may be one possible scenario, another very likely scenario could be something like three to five years or less IF things go well with the regulators and they do what they can to hurry a much needed technology to the market and save many lives by by not being ultra conservative and too picky and allow this regulatory road to proceed on the fastest path consistent with safety and proof of efficacy
So allow the use historic world data, allow the regulatory decisions to be on a tumor and tissue agnostic basis, do not insist on separate individual trials for each and every of the many types of cancer. Given the great safety record of DCVAX, when in doubt err, on the side of approval but require confirming P4 follow up trials to eliminate any continuing doubts and appropriate label information. Do not allow the perfect to become the enemy of the good. Allow strong continuous interaction between the drug company and regulator to greatly hasten the time trials take. Allow for routine use of plans like ORBIS etc that allow for rapid multiple application to many regulators in parallel. Provide for rapid acceptance of approval of foreign regulators who maintain rigorous standards. Much more can be said on this, but I think you get the gist of where I am going. This can be a roadmap for the Cancer Moonshot without even pumping more money into it. Then quickly move on to use the same technology to attack many other diseases besides cancer in the same streamlined fashion!
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