Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

Takeaways from Tuesday's Annual Meeting: With just a single dose, 100%-owned M281 MaB suppresses bad circulating levels of IgG antibodies for up to a month far better than any currently available drug does, and could potentially reach a huge market.

MNTA might try [if they haven't already] FAST TRACK FDA APPROVAL -

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

**Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes. Avoiding serious side effects of an available therapy

**Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome

**Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment

**Ability to address emerging or anticipated public health need

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

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 condition.

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

https://www.fda.gov/forpatients/approvals/fast/ucm405399.htm