US/UK/Canada

Share

Pick a time period -
Tags ( Active)

Scientific Advice from EMA continues

As previously announced, Double Bond Pharmaceutical has submitted a Protocol Assistance request to EMA to obtain scientific advice regarding SI-053 and has now received the answers to their questions. After reviewing the answers, some advice revealed to require a more detailed clarification and the company has therefore sent supplementary questions to EMA to ensure the best strategy for product development in crucial detail and the optimal planning of coming steps. The advice from EMA is be based on a number of questions from DBP mainly

Scientific Advice from EMA is due the first week of March

As previously announced, Double Bond Pharmaceutical has submitted a Protocol Assistance request to EMA to obtain scientific advice regarding SI-053 . The advice from EMA will be based on a number of questions from DBP mainly regarding the preclinical development of SI-053 and the planned Phase I trial in glioblastoma patients. DBP expects useful advice for the product development. Yesterday, DBP were noticed that a final advice letter will be obtained from EMA during the first week in March. The Protocol Assistance is free of charge

Pre-submission meeting with EMA has been completed

As previously announced, Double Bond Pharmaceutical has submitted an application to EMA for scientific advice, known as Protocol Assistance, for SI-053. The Protocol Assistance is given based on questions to EMA that the company prepares in advance regarding the clinical trial protocol for their product, and the quality of these questions is crucial for the outcome of the meeting in the form of value for the company and for product development. Yesterday, Double Bond Pharmaceutical had therefore a pre-submission meeting with EMA and discussed the layout of these questions, before the

DBP gets free Protocol Assistance from EMA for SI-053

Double Bond Pharmaceutical has submitted an application to EMA for scientific advice, known as Protocol Assistance, for SI-053. The assistance will be given during a pre-submission meeting, where DBP is able to get advice on issues and plans that exist for SI-053 before the more formal procedure starts. The assistance is free of charge since the product has orphan drug status, and is expected to be completed in March 2019. Double Bond Pharmaceuticals goal is to then start the clinical trial with SI-053 as soon as possible. “The possibility to consult the agency to discuss the development

The Annual report for Orphan Drug Designation status for SA-033 received no remarks from EMA

Double Bond Pharmaceutical International AB (DBP) has the 20th of September submitted the Annual report for the drug candidate SA-033 to the European Medicines Agency (EMA), which is mandatory after obtaining Orphan Drug Designation status. The Annual report received no remarks or objections, which means that the development of the product is in line with EMA’s requirements and expectations. The company was originally granted Orphan Drug Designation status in June 2015 by EMA for SA-033. The Designation applies to the treatment of hepatoblastoma, which is the most frequent type of liver

There are no items matching the current filter
There are no more items matching the current filter
Back to top

Subscribe