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at any given moment, there are numerous competing trials, collaborations to enroll patients on trials
specific for their disease subtype should be prioritized. Drug development for orphan diseases has
drawbacks and challenges as often the number of patients limits impact, but FDA pathways to prioritize will
continue to help support these efforts.

DECLARATIONS
Acknowledgments
The authors would like to thank the patients and their families. Enrica Marchi would like to thank the U.S.
Food and Drug Administration for their research support through the Orphan Products Development
(OPD) grant #FD-R-006814-01.

Authors’ contributions
Made substantial contributions to conception and design of the study and performed data analysis and
interpretation: Ma H, Marchi E

Availability of data and materials
Not applicable.

Financial support and sponsorship
The U.S. Food and Drug Administration for their research support through the Orphan Products
Development (OPD) grant #FD-R-006814-01.

Conflicts of interest
Helen Ma declared no conflicts of interest. Enrica Marchi reports research support from Merck, Celgene,
and Astex and scientific advisory roles with Myeloid Therapeutic and Kyowa Kirin.

Ethical approval and consent to participate
Not applicable.

Consent for publication
Not applicable.

Copyright
© The Author(s) 2022.

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