Cytodyn Inc (CYDY)

[newmike]

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BTW, I will post if I have something meaningful to add. Right now, we are in a wait and see pattern on both Adjunct and Mono. Until results, there will be a lot of postulation and speculation. I for one do not see MONO being completed by CYDY "IF" Adjunct is compelling. Either A post Adjunct GILD BO, or an FDA Halt on an Iterim Mono readout. Keep in mind Fast Track Designation, and more importantly Rolling Biologic s Licencing Agreement (BLA), or NEW Drug Application (NDA). These Designations are often utilized interchangeably. "Rolling" is what is key. The company can submit intermittent and ongoing data sets, while the trials are commencing...NOT, final Data submission..but ongoing interim submissions. This feeds directly into a perfect AA..Accelerated approval pathway.
1) FDA has established Accelerated Approval pathways, through Fast Track, Orphan Drug and Break Through Therapy (which I hope we soon receive) Designations
2) This is an Unmet Disease State
3) The Cure Act was just passed by the House and Senate
I am hoping the "ROLLING" BLA entices the FDA to expedite the AA process..and perhaps creates a Bidding BO war (that part is my dream, but admittedly a strong part of my position).
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