Followers | 17 |
Posts | 936 |
Boards Moderated | 0 |
Alias Born | 04/26/2010 |
![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Friday, November 30, 2018 5:03:56 PM
![](http://investorshub.advfn.com/uimage/uploads/2018/11/30/cebscFDA_Approvals_2017.png)
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 would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
North Bay Resources Announces Composite Assays of 0.53 and 0.44 Troy Ounces per Ton Gold in Trenches B + C at Fran Gold, British Columbia • NBRI • Jun 18, 2024 9:18 AM
VAYK Assembling New Management Team for $64 Billion Domestic Market • VAYK • Jun 18, 2024 9:00 AM
Fifty 1 Labs, Inc Announces Acquisition of Drago Knives, LLC • CAFI • Jun 18, 2024 8:45 AM
Hydromer Announces Attainment of ISO 13485 Certification • HYDI • Jun 17, 2024 9:22 AM
ECGI Holdings Announces LOI to Acquire Pacific Saddlery to Capitalize on $12.72 Billion Market Potential • ECGI • Jun 13, 2024 9:50 AM
Fifty 1 Labs, Inc. Announces Major Strategic Advancements and Shareholder Updates • CAFI • Jun 13, 2024 8:45 AM