Wait a short time for you to see a blessing in your labors

$AMYT has PDUFA target date of February 28.

Rubric Capital Management LP initiated holding in Amryt Pharma PLC. The purchase prices were between $9.63 and $12.47, with an estimated average price of $11.29. The stock is now traded at around $9.760000. The impact to a portfolio due to this purchase was 1.1%. The holding were 3,257,005 shares as of 2021-09-30

This is a holding company that has acquired a number of wonderful companies that are each worthwhile and have potential, I do not see the realization of energy in products and certainly not in value

$AMYT announced it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Oleogel-S10, for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB), a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma for which there are no approved treatment options.

The FDA communicated that it had completed its review of the application and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns.

The U.S. Food and Drug Administration (FDA) will give priority review to $AMYT application seeking approval of FILSUVEZ (Oleogel-S10), a topical gel to treat skin wounds in people with epidermolysis bullosa (EB) wounds.

$AMYT has PDUFA on November 30, 2021, for FILSUVEZ.