More than half of the 1 in 10 Americans affected by rare diseases are children, and the preponderant majority (95%) of the over 7,000 rare diseases do not have an available therapy.1
For diseases or conditions affecting less than 200,000 individuals in the United States, the FDA Office of Orphan Products Development, OOPD, provides eligible sponsors with two designation programs to facilitate the prevention, diagnosis, and treatment of rare diseases: orphan drug and rare pediatric disease designations.2
https://mmsholdings.com/perspectives/fda-expe...velopment/
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Per Dr. J, the high net worth sponsor is funding as needed: Prostate, Pancreatic, Urothelial Cancers &
Sarcoma.
Sarcoma is a rare disease due to less than 200k new cases per year. Also around 15-20% child brain tumors.
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We know Mr. Hoffman said will be seeking Orphan Drug Status.
FDA Rare Disease Innovation Hub:
https://www.fda.gov/industry/medical-products...vation-hub
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"and the preponderant majority (95%) of the over 7,000 rare diseases do not have an available therapy."
This site search engine says over 10k RD's....
https://rarediseases.org/rare-diseases/
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Cytodyn is very possibly positioning LL + ICI for Glioblastoma, Pancreatic & Sarcoma, to start the process of a qualifying Rare Disease treatment and opening the window to all Rare Diseases expressing CCR5.
As a brainstorm after the FcRn abstract, i said LL/LL-PLS could become the cornerstone to a new medical hub.
Well now with Cold / Hot & Prime n Pair.....& Orphan Drug designation potential ---- Wow !!
For diseases or conditions affecting less than 200,000 individuals in the United States, the FDA Office of Orphan Products Development, OOPD, provides eligible sponsors with two designation programs to facilitate the prevention, diagnosis, and treatment of rare diseases: orphan drug and rare pediatric disease designations.2
https://mmsholdings.com/perspectives/fda-expe...velopment/
___
Per Dr. J, the high net worth sponsor is funding as needed: Prostate, Pancreatic, Urothelial Cancers &
Sarcoma.
Sarcoma is a rare disease due to less than 200k new cases per year. Also around 15-20% child brain tumors.
___
We know Mr. Hoffman said will be seeking Orphan Drug Status.
FDA Rare Disease Innovation Hub:
https://www.fda.gov/industry/medical-products...vation-hub
___
"and the preponderant majority (95%) of the over 7,000 rare diseases do not have an available therapy."
This site search engine says over 10k RD's....
https://rarediseases.org/rare-diseases/
___
Cytodyn is very possibly positioning LL + ICI for Glioblastoma, Pancreatic & Sarcoma, to start the process of a qualifying Rare Disease treatment and opening the window to all Rare Diseases expressing CCR5.
As a brainstorm after the FcRn abstract, i said LL/LL-PLS could become the cornerstone to a new medical hub.
Well now with Cold / Hot & Prime n Pair.....& Orphan Drug designation potential ---- Wow !!
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