Because the base platform is new and never before done, all of the characterization studies done up to now would have been required whether it was for one drug or for four. The FDA wants to see a multitude of animal studies even if it were just FluCide or HSV-Cide. That's something that has been repeated here, yet there is still this sense that two aggressive protocols that saves some mice is enough. It's not enough. The FDA wants a dozen studies all showing in every case that there was no indication of tissue damage at estimated therapeutic levels. They want the base nanomicelle proven, not just the indication. All the testing for the base platform must be done anyway, so why not develop 3 or 4 drugs as candidates where one is poised to follow another once the first gets into human testing.
Of course many, including the docs, thought that FluCide and Rabicid would get accelerated approval based on no therapeutic equivalent, but that didn't happen with the first two FDA contacts. Too novel? Too good to be true? Too paradigm shifting for established vaccine based fossilized viewpoints? Probably.
The pre-IND package will include all the data for all tests. No matter which one is first--HIV, Flu, Dengue--all data for all testing will be reviewed. It is all one package until the final tox evaluation begins. Then all the testing will be limited to one disease, the Chosen One.
The question I have is now that the docs have announced a firm goal, now that a two year course is established, why is it now so many are supposedly frustrated by the process? Why is it now that there is such a tone in the discussion that the length of time is poor management and not the result of a culture that places safety above all else, including saving lives that would otherwise be lost anyway?
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