(Total Views: 181)
Posted On: 03/03/2019 2:53:01 PM
Post# of 151731
Yes, apparently there is some negotiations still ongoing with the FDA on the length requirements for the safety data, which is making the timeline not as firm. NP said once that was done, they would announce the firmer timeline.
3:49 produced a hundred patients data we will
13:52 have to see how fast we can get that
13:54 data that they asked for and how long
13:56 each patient has to go for we are in
13:58 discussions with FDA
36:39 we have already started
36:42 injecting patient with 700 milligram
36:45 quite a bit of time before even the FDA
36:48 asked for that data so we are working on
36:51 that very carefully there is a timeline
36:54 that they want these patients to pass
36:56 certain points and we're going to be
36:59 negotiating with FDA at this time we are
37:01 accepting everything FDA said but
37:03 hopefully in future if we're able to get
37:05 better timeline then we can do it faster
37:07 but we do have some patients already
37:10 with 700 milligrams
37:12 their data and we are going to have a
37:16 much firmer timeline and announced that
37:19 at the given time
3:49 produced a hundred patients data we will
13:52 have to see how fast we can get that
13:54 data that they asked for and how long
13:56 each patient has to go for we are in
13:58 discussions with FDA
36:39 we have already started
36:42 injecting patient with 700 milligram
36:45 quite a bit of time before even the FDA
36:48 asked for that data so we are working on
36:51 that very carefully there is a timeline
36:54 that they want these patients to pass
36:56 certain points and we're going to be
36:59 negotiating with FDA at this time we are
37:01 accepting everything FDA said but
37:03 hopefully in future if we're able to get
37:05 better timeline then we can do it faster
37:07 but we do have some patients already
37:10 with 700 milligrams
37:12 their data and we are going to have a
37:16 much firmer timeline and announced that
37:19 at the given time


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