Replies to post #155259 on 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.

[corporalagarn]

Thanks Semper. I wonder if there is information available on the success rate of drugs granted fast track status as opposed to drugs going through the regular phase III process. I think the fast track status is definitely a plus despite the current pps. Looking forward to PPHM finalizing the financing situation. Pretty sure they are not going to fund this PIII with the ATM.

[dia76ca]

Thanks again to semper for posting the advantages of the Fast Track!...here are some of the advantages.

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Incentives
*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 correspondence from FDA about such things as the design of the proposed clinical trials
*Eligibility for FDA Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit
*Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA
*Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.

In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious disease.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
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