research reports and media, page-2222

thanks Moz - the thing that got me is that if you do get fast track you seem to have a direct line to the FDA as per below:

A drug that receives Fast Track designation is eligible for some or all of the following:

• More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
• More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Would it not be beneficial to have the FDA reviewing our early results as per above they can submit completed sections rather than wait and send all information at the end. I would just be interested to see the companies thinking. I guess they could be waiting a little down the track once the trials start but would hope that they are going to apply at some point. It would appear that the FDA will almost mentor the company if they receive fast track approval. I wonder how many fast tracked drugs have failed in there New Drug Application as surely it has to improve chances of approval.