RE:RE:RE:the clock is tickingO12009 wrote: And there you have it. The FDA only wants to see patients data that has completed the trial 63.The data numbers is getting better with each patient so they are waiting. AA they look at all the patients and the safety profile is taken into consideration. We should be looking at that in second quarter.
I guess I didn't make it clear enough when I posted this a couple days ago. The BTD hasn't been applied for yet. The FDA only wants to see the 63 patients data that has completed the trial period. We are waiting for some more patients data to be completed that will make the numbers better. The numbers are better as the trial and treatment procedures improves. This will happen in the next three weeks. For BTD the safety profile is not a major part of the process. But for accelerated approval the safety profile is included and all of the patients will be included, which will give Theralase a very good chance of success.We will be applying for AA in the second quarter.
GLTA