Information for FDA - why the timing? Management: “We believe we have the data and information to address FDA’s questions”.
Prokofiev: I had posted last week that I expect Helius to resubmit its data in the next 2-5 weeks, but I believe pushing this out by a week to be more realistic. Therefore, my new estimate is 3-6 weeks.
If management has the data and information, why should it take 3-6 weeks to get it to the FDA?