Hi Chop- I find this interesting, address an unmet need where an...

Hi Chop- I find this interesting, address an unmet need where an approved therapy exists. Fits with Rem-l vs Rux in adult severe cases.
Still looking for the goose ........ with the FDA seemingly more progressive maybe Nicole Verdun is across Rux failure.

For a sponsor or applicant who seeks fast track, priority, breakthrough, RMAT or accelerated approval designation review, approval is required to submit a request showing that the drug product: (1) is intended for a serious or life-threatening condition and (2) has the potential to (a) address an unmet medical need, (b) demonstrate substantial improvement over available therapy, or (c) fill an unmet need to be approved based on a surrogate endpoint. We expect that most information to support a designation request will have been gathered under existing requirements for preparing an investigational new drug (IND), new drug application (NDA), or biologics license application (BLA). If such information has already been submitted to us, the information may be summarized in the designation request. A designation request should include, where applicable, additional information not specified elsewhere by statute or regulation. For example, additional information may be needed to show that a product has the potential to address an unmet medical need where an approved therapy exists for the serious or life-threatening condition to be treated. Such information may include clinical data, published reports, summaries of data and reports, and a list of references. The amount of information and discussion in a designation request should be sufficient to permit a reviewer to assess whether the criteria for fast track, priority, breakthrough, RMAT or accelerated approval designation have been met.

Reg