HOME >> BIOLOGY >> NEWS
SinuNase IND on track

Accentia Biopharmaceuticals (Nasdaq: ABPI) was pleased to receive confirmation recently from the Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for the Company's proprietary drug SinuNase will remain under the direction of the Special Pathogens and Transplant Products (SPTP) section of the Centers for Drug Evaluation and Research (CEDR) of the Food and Drug Administration (FDA).

Accentia proposes to move forward with its first phase 3 study on recurrent post-surgical chronic sinusitis patients, and would like to include in its confirmatory phase 3 study additional patients who suffer from moderate to severe chronic sinusitis but have not had surgery, in order to seek an expanded label indication when the drug launches.

As a result of this determination that the IND will remain under the supervision of the Special Pathogens and Transplant Products section of the FDA, Accentia is consulting with that section on its development program for SinuNase, including whether or not it is advisable for the Company to resubmit an application for a special protocol assessment before commencing the first phase 3 study.

On Nov, 14, 2005 Accentia had disclosed that it had been notified by the FDA that its IND for SinuNase might be transferred to another division of the FDA, and the Company disclosed that it had voluntarily withdrawn its submission of a special protocol assessment agreement (SPA) for its first phase 3 study of SinuNase, pending resolution of the proposed transfer.

"A special protocol assessment identifies the exact label claim the clinical trial will support if successful, and it is specific to each phase 3 clinical study," explains Frank E. O'Donnell, Jr., M.D., Chairman and CEO of Accentia. "Both the Company and the FDA agree that statistically significant evidence showing that SinuNase precludes the need to resort to surgery to control severe chronic sinusitis would be beneficial, as th
'"/>

Contact: Adam Holdsworth
aholdsworth@investorrelationsgroup.com
212-825-3210
The Investor Relations Group
14-Feb-2006


Page: 1 2

Related biology news :

1. Satellite tracking reveals threats to Borneo pygmy elephants
2. Satellite tracking will help answer questions about penguin travels
3. Species detectives track unseen evolution
4. Better sleep may put Huntingtons disease sufferers back on track
5. Biovest announces interim blinded data of fast-tracked pivotal Phase 3 clinical trial of BiovaxID
6. TU Delft tracks the influence of a cancer inhibitor on a single DNA molecule
7. Researchers track snakes to study populations, behavior
8. Researchers track how spores break out of dormant state
9. Salmon tracking program expands to California
10. Simple equations track Listeria trails
11. Bat flight generates complex aerodynamic tracks

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:7/2/2020)... Md. (PRWEB) , ... July ... ... Molecular Biology Systems, B.V. (MBS) has announced a publication detailing the use ... one-step reverse transcription polymerase chain reaction (RT-PCR) in 16 minutes. The article, ...
(Date:7/1/2020)... ... July 01, 2020 , ... Cure Glioblastoma, a ... most common and aggressive adult brain cancer—announced today the appointments of its first ... charged with supporting the organization’s initiatives and overall vision. , "Senior Fellows are ...
(Date:6/28/2020)... ... June 25, 2020 , ... In an upcoming episode scheduled for ... Point of Care Testing solutions (POCT). Check local listings for more info. , Today, ... offices and are shipped to labs throughout the country. Results are then available several ...
Breaking Biology News(10 mins):
(Date:7/10/2020)... ... July 08, 2020 , ... Bode ... significant expansion of laboratory operations through its COVID-19 testing service, Bode-CARES . ... , Bode-CARES provides a turnkey solution that includes a comprehensive ...
(Date:7/10/2020)... ... July 09, 2020 , ... ... today announced the hiring of Allen R. Nissenson, M.D., F.A.C.P., as its Chief ... clinical development of Sentien’s lead product, SBI-101. Dr. Nissenson serves as an ...
(Date:7/1/2020)... , ... June 29, 2020 , ... ... to date growth of 40% in 2020, despite many obstacles created as a ... aims to increase revenue for its partnered medical practices and medical manufacturers by ...
(Date:6/28/2020)... LAGUNA NIGUEL, Calif. (PRWEB) , ... June 25, 2020 , ... ... today announced the launch of Safe Space™ for businesses of all types to ensure ... and 3D LiDAR. , A Safe Space™ enabled business will provide a ...
Breaking Biology Technology:
Cached News: