RE:Pre-BTD week?It's been confirmed that a reply within 2 to 3 weeks of filing is expected. My guess is that a meeting has been booked for this week.
BTD requires at least 25 patients, needs to be safe, more effective than currently available treatments, duration must be shown at 2 and 3 years. And Pathology reports from a "centralized" lab. Finally, ideal if it meets or exceeds stated Wishlist goals (50% 30% 25%).
Many on this board feel Theralase has satisfied all criteria.