(Total Views: 400)
Posted On: 11/30/2018 6:00:44 PM
Post# of 72446
Really good post from plentyparaniod from swamp.
I noticed that there has been number of messages about how crucial breakthrough designation (BTD) is for the future of B-OM and hence survival of IPIX. Here is some historical background for that discussion.
[Suppressed Image]
Currently Brilacidin has Fast Track designation (FTD) but not Breakthrough designation (BTD) and it looks like BTD is not coming.
Last year (2017) FDA approved 46 novel drugs.
18 of the approved drugs had FTD.
17 of the approved drugs had BTD.
9 of the approved drugs had both FTD and BTD.
28 of the approved drugs had FDA granted Priority Review for NDA/BLA application.
Here is the interesting part. One might assume that BTD would results in FDA granting more Priority Reviews for drugs with BTD than for drugs with just FTD (BTD being so 'crucial'). Not so, as one can figure out from the above table. ALL approved drugs with FTD had also priority review, so did ALL approved drugs with BTD.
In case someone asks - Priority Review is not automatic consequence of either FTD or BTD. (can't help it, but I do sound like discussing about some disease)
I noticed that there has been number of messages about how crucial breakthrough designation (BTD) is for the future of B-OM and hence survival of IPIX. Here is some historical background for that discussion.
[Suppressed Image]
Currently Brilacidin has Fast Track designation (FTD) but not Breakthrough designation (BTD) and it looks like BTD is not coming.
Last year (2017) FDA approved 46 novel drugs.
18 of the approved drugs had FTD.
17 of the approved drugs had BTD.
9 of the approved drugs had both FTD and BTD.
28 of the approved drugs had FDA granted Priority Review for NDA/BLA application.
Here is the interesting part. One might assume that BTD would results in FDA granting more Priority Reviews for drugs with BTD than for drugs with just FTD (BTD being so 'crucial'). Not so, as one can figure out from the above table. ALL approved drugs with FTD had also priority review, so did ALL approved drugs with BTD.
In case someone asks - Priority Review is not automatic consequence of either FTD or BTD. (can't help it, but I do sound like discussing about some disease)
(2)
(0)
