Tuesday, February 21, 2017 11:50:20 AM
_______________________________________________
What Other Types of Vouchers Exist?
To date, only one other type of voucher exists: The Rare Pediatric Disease Priority Review Voucher.
The rare pediatric voucher was created in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), and specifically targets the need for additional therapies for rare pediatric subsets of other diseases.
Section 908 of FDASIA defines a "rare pediatric disease" as one which "primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children and adolescents," and is a rare disease according to federal statute (200,000 persons in the US or fewer).
The rare pediatric voucher system is closely modeled off the tropical disease voucher system, with several exceptions. Perhaps the most notable difference at the time of the pediatric voucher's initial passing was its relative ease of use. Unlike the tropical voucher, which required FDA to be notified 365 days prior to its use, the rare pediatric voucher could be used just 90 days prior to its use.
Another key difference: The rare pediatric voucher could be transferred (i.e. sold) an unlimited number of times, unlike the tropical disease voucher which could only be sold once.
However, as of December 2014, both of these differences have been erased under the Adding Ebola to the FDA Priority Review Voucher Program Act, which eliminated the disparity between the two vouchers. Tropical vouchers may now be redeemed in just 90 days, and may be resold an unlimited number of times.
FDA has also indicated that the vouchers will require the same user fee.
- See more at: http://www.raps.org/Regulatory-Focus/News/2015/07/02/21722/Regulatory-Explainer-Everything-You-Need-to-Know-About-FDA%E2%80%99s-Priority-Review-Vouchers/#sthash.xkebF4yD.dpuf
Lot of info there. It is new to me. Seems like GILD got a good deal. Bullish blog about GILD's advantage on SA.
GILD
Recent GILD News
- U.S. Futures Drop in Pre-Market Trading as Tech Stocks Plunge After Meta Issues Gloomy Forecast • IH Market News • 04/25/2024 11:53:54 AM
- Gilead Sciences to Release First Quarter 2024 Financial Results on Thursday, April 25, 2024 • Business Wire • 04/08/2024 08:05:00 PM
- FDA Expands Indication for Gilead's Vemlidy (Tenofovir Alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six • Business Wire • 03/28/2024 12:30:00 PM
- Gilead and Xilio Announce Exclusive License Agreement for Tumor-Activated IL-12 Program • GlobeNewswire Inc. • 03/28/2024 11:00:00 AM
- Gilead and Xilio Announce Exclusive License Agreement for Tumor-Activated IL-12 Program • Business Wire • 03/28/2024 11:00:00 AM
- Gilead Sciences Announces Completion of Acquisition of CymaBay • Business Wire • 03/22/2024 01:18:00 PM
- Center for Disease Analysis Foundation Announces First Round of Grantees for the CDAF-Relink Grant • Business Wire • 03/18/2024 11:29:00 PM
- Form SC TO-T/A - Tender offer statement by Third Party: [Amend] • Edgar (US Regulatory) • 03/11/2024 12:34:07 PM
- Gilead Sciences Announces Expiration of Hart-Scott-Rodino Waiting Period for CymaBay Tender Offer • Business Wire • 03/11/2024 12:24:00 PM
- Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities • Business Wire • 03/06/2024 09:30:00 PM
- Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24 • Business Wire • 03/06/2024 03:25:00 PM
- Gilead and Merus Announce Collaboration to Discover Novel Antibody-Based Trispecific T-Cell Engagers • Business Wire • 03/06/2024 01:00:00 PM
- New Real-World Data Further Support the Use of Veklury® (Remdesivir) for People Hospitalized With COVID-19 • Business Wire • 03/05/2024 09:35:00 PM
- Gilead’s Innovative HIV Treatment Research Pipeline Aims to Address Unmet Needs and Advance Public Health • Business Wire • 03/05/2024 09:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 11:35:55 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/29/2024 09:49:46 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/28/2024 09:38:50 PM
- Gilead Announces Funding Initiative to Support HIV Prevention, Anti-Stigma and Health Equity Efforts for Black Cisgender and Transgender Women and Girls in the U.S. • Business Wire • 02/27/2024 03:00:00 PM
- U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance • Business Wire • 02/26/2024 09:05:00 PM
- Gilead to Present Late-Breaking Data and Real-World Evidence Highlighting Innovative Antiviral Portfolio and Research Pipeline at CROI 2024 • Business Wire • 02/26/2024 01:30:00 PM
- Form SC TO-T - Tender offer statement by Third Party • Edgar (US Regulatory) • 02/23/2024 11:09:33 AM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/20/2024 09:31:04 PM
- Gilead Sciences to Present at Upcoming Investor Conferences • Business Wire • 02/20/2024 09:05:00 PM
- Form SC TO-C - Written communication relating to an issuer or third party • Edgar (US Regulatory) • 02/14/2024 10:08:14 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/13/2024 10:48:49 PM
FEATURED Cannabix's Breath Logix Alcohol Device Delivers Positive Impact to Private Monitoring Agency in Montana, USA • Apr 25, 2024 8:52 AM
Bantec Reports an Over 50 Percent Increase in Sales and Profits in Q1 2024 from Q1 2023 • BANT • Apr 25, 2024 10:00 AM
Kona Gold Beverages, Inc. Announces Name Change to NuVibe, Inc. and Initiation of Ticker Symbol Application Process • KGKG • Apr 25, 2024 8:30 AM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM