government orders intravenous relenza, page-10

I recall from the july transcript at the nbsb meeting, the GSK spokesperson (Ng-Cashin) stated that they had a few hundred doses of iv relenza for compassionate use. I’ve cut and pasted the dialogue from page 80 and 81.

Dr. Gellin: We heard about the European Medicines Agency (EMEA) approach. How is this working outside the United States?
Dr. Ng-Cashin: With IV-zanamivir, the European regulators were the same as FDA. In 2007, they wanted to wait to find out what FDA said.

Dr. Pavia: Regarding the size of the stockpile, are we considering the right strategy? I hope that’s being discussed. Dr. Robinson of BARDA echoed the urgency of the situation, and we came to a boiling point yesterday. We’re in a similar place for this. Some of the drugs can be used under EUA, and that pathway has to be considered. GSK did not discuss EUA.
Dr. Ng-Cashin: We have not considered that in the past. We were discussing with FDA what we currently have - 450 courses of IV-zanamivir for compassionate-use using an emergency IND. We might consider EUA. I can’t decide that, but we have the active ingredients. We welcome more conversation with FDA.


This is big: HHS has ordered 10K iv relenza now, and the option of 30k over the next couple of years. Consider also, at least in this case, that European regulators have been looking to see what the FDA does regarding iv relenza.
GSK has been talking to 60 countries about relenza, they’ll be enquiring about iv relenza too.

It’s not too much of a stretch to imagine 30 European countries requesting 5-10K of iv relenza right now. Furthermore, it looks to me like GSK has been coerced into producing iv relenza for the next couple of years. The bonus will be if GSK can design and complete a phase 3 clinical trial of iv relenza that satisfies the requirements of the FDA.
Cheers,