Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

In the recent SEC filing Javitt mentions that they plan on applying for Breakthrough therapy designation. It’s essentially the next step from Fast track after preliminary data is submitted in order to expedite drug development and full approval for a life saving drug. ———

After reading a bit on it I found this little nugget on the FAQ. ———

Does a sponsor have to request breakthrough therapy designation in order to be considered for the designation? ———

A sponsor needs to submit a request for breakthrough therapy designation in order to be considered for the designation.  In some cases, FDA may suggest that the sponsor consider submitting a request for breakthrough therapy designation if: (1) after reviewing submitted data and information (including preliminary clinical evidence), FDA thinks the drug development program may meet the criteria for breakthrough therapy designation, and (2) the remaining drug development program can benefit from the designation. ———

We know they met with FDA before filing for EUA. We can’t say for certain if FDA suggested that we apply for breakthrough therapy designation but we can infer it was most likely discussed. ———

If the FDA suggested it we fit the criteria and timing perfectly. I can’t see how the FDA would suggest Breakthrough while denying EUA. All the pieces are coming together. ~ from Kpags, Y@h00 finance conversations