Replies to post #44149 on NanoViricides Inc. (NNVC)

[philsdaddy]

In my previous post I responded as I did because I felt my credibility was being assailed. I believe in NNVC and I promote it to most everybody with whom I have conversational communication. When I post something, it is either my belief or information I have garnered/researched and I hope it may be of value to others here on the board. I failed to provide the link for the FDA information I posted, as it didn't occur to me that the veracity of the information would be questioned. I'll be sure and post links when I cut and paste in the future. I reacted a bit harshly to the inferred slight and I apologize to Dr Feelgood for that action. We all here (well, most all here) want to see NNVC succeed and we all want to make the most educated decisions/guesses we can as to how to invest our money. I appreciate that we have such a positive and open forum for our communication. I am still looking forward to our Hawaii adventure, as all of us newly-minted millionaires reap our riches. Oh, one other thing--as a vegetarian I will not be able to eat the pig, or any other meats or seafood--I will have to content myself with poi and pineapple!
Lee

[BonelessCat]

I apologize for my assumption that the guidelines were non-FDA summaries. However, the FDA seems to be in disagreement with itself:

"For patients who have no remaining treatment options and are at imminent risk of disease
progression secondary to severe immunodeficiency, participation in randomized
controlled registrational trials may not always be desirable. For such patients,
participation in open-label, compassionate-use safety studies or expanded access studies
may be more appropriate. This was the consensus of the advisory committee panel held
on January 2001. The Division encourages sponsors with promising new drugs to
develop access protocols as soon as safely feasible in the drug development plan for
patients in need. Trial design considerations for studies of heavily treatment experienced
patients are addressed further in section III. C., Efficacy Considerations for Accelerated
Approval."

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf

Under section III C, compassionate use can come as early as Phase 1. For HIV, Phase 1 has included several end of life, heavily treatment experienced patients.