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Re: Rawnoc post# 121971

Tuesday, 06/07/2016 3:20:21 PM

Tuesday, June 07, 2016 3:20:21 PM

Post# of 146299
Since you are keen to discuss NNVC's "competition" such as BIND therapeutics (now bankrupt) and Ansun, with their FluDase, can you tell us all what is happening with FluDase development, which you claim is responsible for winning this great award?

I'll repeat my questions to you from last Friday, which you haven't answered yet:



First Phase II influenza study:

https://clinicaltrials.gov/ct2/show/NCT01037205

was reported here:

http://jid.oxfordjournals.org/content/206/12/1844.long

"The primary endpoints were change in viral load as measured by polymerase chain reaction (PCR) using area-under-the-curve (AUC) metric as well as safety."

"No differences in viral load were observed between the treatment groups when examining the AUC metric."

and worse, it didn't improve clinical symptoms:

"Unfortunately, the authors were unable to demonstrate a significant difference in the time to resolution of clinical symptoms."

What about this second Phase II study?

https://clinicaltrials.gov/ct2/show/NCT01740063

Ansun finished this "pivotal" phase IIb study in influenza 3 years ago. Where were the results reported? Why aren't they running a phase III study or applying for a NDA 3 years later?
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