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michelinvests

08/20/17 2:52 PM

#16706 RE: woodenbear #16705

“PRO 140 administered as a single agent provided maximal virologic suppression and was well tolerated by 10 HIV-infected patients for nearly two years.”

http://ir.cytodyn.com/press-releases/detail/254/data-presented-at-croi-show-cytodyns-pro-140-as-a-single

tonysd57

08/20/17 8:30 PM

#16707 RE: woodenbear #16705

Another side note to this story is the positive impact the 21st Century Cures Act will likely have which raises the level of desire and valuation. Passed last December, the Science Board recently submitted in June it's "work plan" for innovation activities & monetary allocations.

In both the legislation and work plan a consistent and prominent drumbeat has been the emphasis and need ( really a mandate) for patient engagement and DIRECTS the FDA to include the patients voice in drug development & review.

While it's true most large government agencies are slow to adopt change, the FDA seems eager to reinvent itself to help stay abreast of fast moving technology. I view them as our ally. We've been walking down the aisle hand in hand so to speak and they're intimately aware of what PRO-140 can do.

As well as section 3001 of the Cures Act mentioned above, other sections speak to using "real world" data and evidence to support approval of new indications or satisfy post approval study requirements or section 3016 that will study the significant advantages of continuous manufacturing as opposed to batch manufacturing of small molecule drugs.

Many of the rules ratified within this act go right to the heart of what PRO-140 is trying to accomplish and removing barriers to approval and manufacturing only enhance the desirability and value of the product- I'm sure its not lost on BP that their certainly could be a much quicker path to approval & sales with PRO-140 than most other drug therapies-