Cytodyn Inc (CYDY)

[chumppunk]

Forbes article. The HIV community has a very strong political backing in Wash. The show wasn't a SP rally. Charlie and many more are in need of a new form of treatment. Everything discussed was factual. The BTD results will obviously benefit the SP which is due out any day till March 23rd.
Chump
This is copied from the FDA's site- BreakThrough Designation Guidance

" The accelerated approval pathway has been used primarily in settings in which the disease course is long and an extended period of time would be required to measure the intended clinical benefit of a drug. For example, accelerated approval has been used extensively in the approval of drugs to treat a variety of cancers and human immunodeficiency virus (HIV) disease where an effect on tumor growth or viral load can be assessed rapidly, but demonstrating an effect on survival or morbidity generally requires lengthy and sometimes large trials because of the duration of the typical disease course."

And

'Examples of surrogate endpoints that FDA has used to support accelerated approval include the following:
• Prolonged suppression of HIV viral load in plasma has been shown to reduce the morbidity and mortality associated with HIV disease and has been the basis for traditional approval. Shorter-term suppression of viral load has been used in the past as a surrogate to support accelerated approval because it was considered reasonably likely to predict an effect on morbidity or mortality. Data now demonstrate that short-term suppression of viral load may support full approval, in some circumstances.'