RE:not sure about the wordingI don't think they have submitted a 2nd pre-BTD as they say "Theralase has received the majority of the clinical data from the CSSs" so it seems that is the hold up but sounds like they are very close. This seems to me like a pretty stock update, like the last few just change a few numbers, and we will hear more hopefully on the call. I see no change, just waiting on the remainder of the data to come in, maybe Roger can expand.
DJDawg wrote:
It will be interesting to hear clarification on the investor call Dec 4 as I'm not sure about the wording around the pre-btd. It is so similar to previous that I don't know if I am convinced that it is saying, we resubmitted for pre-BTD and now, for the 2nd time, they want clarification. That would make the 3rd crack at pre-BTD which is absurd as usually if you are not BTD worthy you get that feedback on the first or second go. Having the FDA say, no but try again in a month makes no sense.
So I'm confused.