at PG / BMSN
in your post 92184 (yesterday), you said that "the fact that the GENERATED efficacy data has been submitted to the FDA for hopefully what will be the final submission to them before the approval of HemaXellerate". Yes, the Co PR in July, para # 5 did say it as follows
5. Based on experiments that FDA requested, the company generated new data further demonstrating efficacy of HemaXellerate I™ in animal models. This may be seen in the figure attached.
However, in the same PR, it said "The Company is extremely appreciative of the input it has received from the FDA and looks forward to addressing their concerns within the next several months." This statement is saying the Co is working on the get all information requested by FDA within several months.
Does it sound contraditing each other?
