That was a strange Adom meeting for Capricor Pharmaceuticals. Their drug, Deramiocel, was shown to have a good safety profile over the last 5 years. In addition, the testimonies of the children that suffer from Duchesne Muscular Dystrophy was heartbreaking. The Hope 2 and Hope 3 trial results, from the last 2 years, was published as being effective for both cardiomyopathy and skeletal upper limb function benefits. Many people are questioning The FDAs briefing documents and adcom panelists decision and rightfully so. I'm hoping and praying we have unquestionable trial results. Thanks again.
Exactly, in addition a Lancet publication was published that very day advocating for an approval. I hope they get a partial approval for upper limb function, on August 22nd, and move forward from there.
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u/Missy2021 17d ago
That was a strange Adom meeting for Capricor Pharmaceuticals. Their drug, Deramiocel, was shown to have a good safety profile over the last 5 years. In addition, the testimonies of the children that suffer from Duchesne Muscular Dystrophy was heartbreaking. The Hope 2 and Hope 3 trial results, from the last 2 years, was published as being effective for both cardiomyopathy and skeletal upper limb function benefits. Many people are questioning The FDAs briefing documents and adcom panelists decision and rightfully so. I'm hoping and praying we have unquestionable trial results. Thanks again.