PPMD Advocates Ensure Congress Recognizes Importance of Flexibility in FDA Reviews
Posted by PPMD on April 19, 2016 at 4:00pm
Yesterday, the Federal Appropriations Report Language for the FDA was posted and included the language submitted by our Congressional champions at the request of our PPMD community (download the full report). "Report language" is specific direction Congress gives to federal agencies when they receive their budgets. Your efforts have once again yielded success, the FY17 language reads:
"Duchenne Muscular Dystrophy.—The Committee is encouraged that the FDA has the tools, authorities,and latitude necessary to review and approve safe and effective treatments for rare diseases, such as Duchenne Muscular Dystrophy, as efficiently as possible. In particular, the Committee is aware that the use of intermediate clinical endpoints (ICE) may be an appropriate approach as it has been in similar deadly diseases with dire unmet needs, such as HIV and cancer."
and thanks !
$SUNE Turns out They Are Financially Good, Booted The CEO, New CEO Game Changer, Buy Opportunity , What a price !!!
$SUNE Co has $ Billions in new sales, correct. This is all rumors or someone will buyout with $ billions in deals.
The rally by Acadia comes after FDA staff members said the company's Parkinson's drug Nuplazid was effective in treating psychosis associated with the disease.
great buy opp for those like us that know.
see ya there !
DO THE DD
Celator Pharma Breakthrough Trial Results
The percentage of patients alive 12 months after randomization was 41.5% on the Vyxeos arm, compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the
Vyxeos arm, compared to 12.3% on the 7+3 arm. Less
by Madeleine Johnson Published on March 23, 2016 |
Celator announced positive results from a Phase 3 trial of its drug Vyxeos in patients with high-risk acute myeloid leukemia (AML) Celator has the potential to be the next big star of the biotech industry, and is an opportunity for investors looking to invest in a company right from the get go.
good luck went long.