Monday, January 14, 2019 11:06:12 AM
The target Accelerated Approval review timeline is 6 months.
http://www.pharmexec.com/how-fast-are-fda-fast-lanes
Also when looking at a fabry candidate drug that was looked at for accelerated approval we can see the FDA target for review again was 6 months.
http://www.pmlive.com/pharma_news/sanofi_gains_accelerated_review_for_rare_disease_drug_722639
Given this being the case, and that PLX mentioned holding discussions with the FDA for Accelerated Approval in 1Q 2019, may mean that if they submit the documentation in 2Q 2019, that we could have PRX-102 approval by end 2019. Again as mentioned when looking over the new FDA guidelines and that Fabryzyme and Galafold were approved under the Accelerated Approval pathway, that I would feel this would seem a strong possibility.
Recent PLX News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 11:02:59 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 10:56:02 AM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 05/17/2024 09:05:17 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/17/2024 09:00:28 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 11:20:49 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/10/2024 10:59:36 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/02/2024 11:36:07 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/26/2023 11:56:21 AM
- Levicept Appoints Eliot Forster as CEO • GlobeNewswire Inc. • 11/30/2023 09:00:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/06/2023 12:50:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/06/2023 12:22:32 PM
- Upcoming Earnings Release Paired With Price Target Raise Sends Stock Soaring • AllPennyStocks.com • 10/31/2023 08:40:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/20/2023 10:50:07 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/03/2023 09:00:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/03/2023 09:00:54 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/03/2023 09:00:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/03/2023 09:00:50 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM