Avid Bioservices Inc (CDMO)

[Hellassss]

Great summary Semper!

I love many parts, that (for me) demonstrate how the FTD is an indirect validation of a third party (FDA) that Bavi works. (or at least to date shows that works).


Such status is often given to agents that show promise in treating serious, life-threatening medical conditions for which no other drug either exists or works as well.

Fast Track addresses a broad range of serious diseases. Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.

a fast track drug must show some advantage over available treatment, such as:
*Showing superior effectiveness
*Avoiding serious side effects of an available treatment
*Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
*Decreasing a clinically significant toxicity of an accepted treatment

*Eligibility for FDA Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit

In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review.

The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.