This post from actionnaire on the PYC forum, with commentary...

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hottod

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23/04/25

10:26

Post #: 78772953
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Originally posted by hottod ↑

While there has been concern about the impact of Trump administration changes at the FDA on rare disease developers, the new FDA Commissioner, Dr. Marty Makary, has soothed nerves by making clear his support for and prioritization of the sector.

17 April

FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees

In keeping with U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s promise to carry out the Department’s work with “radical transparency” and mitigate perceived industry influence and conflicts of interests, FDA Commissioner Martin A. Makary, M.D., M.P.H., announces a policy directive that limits individuals employed at companies regulated by the U.S. Food and Drug Administration, such as pharmaceutical companies, from serving as official members on FDA advisory committees, where statutorily allowed. As part of this effort, the agency will prioritize and elevate the role of patients and caregivers, strengthening the voices of their communities.

https://www.fda.gov/news-events/pre...y-individuals-serving-fda-advisory-committees

21 April

Biotech stocks climbed Monday after new FDA Commissioner Dr. Marty Makary laid out a clear and collaborative regulatory strategy that analysts say bodes well for drug developers. In his first major interview since taking office, Makary emphasized pragmatic reforms, faster drug approvals, and modernized use of real-world data across the agency.

With biotech stocks still recovering from recent sector-wide weakness, RBC believes the Makary interview could serve as a sentiment boost by reinforcing regulatory stability and predictability. Investors are now seemingly reassessing names positioned in orphan and accelerated approval pathways in light of the evolving FDA leadership tone.

https://au.finance.yahoo.com/news/biotech-stocks-jump-makary-outlines-202606821.html

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This post from actionnaire on the PYC forum, with commentary from US investment bank, Stifel, provides some more insight on this topic.

https://hotcopper.com.au/threads/an...inical-trial.8533587/page-24?post_id=78761243

NEU Price at posting: $10.82 Sentiment: Hold Disclosure: Held
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Last $16.78		Change 0.150(0.90%)		Mkt cap ! $2.117B

Open	High	Low	Value	Volume
$16.80	$16.90	$16.63	$1.036M	61.77K

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No.	Vol.	Price($)
2	81	$16.77

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Price($)	Vol.	No.
$16.78	22	1

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No.	Vol.	Price($)
5	74	16.810
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5	942	16.770

Price($)	Vol.	No.
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This post from actionnaire on the PYC forum, with commentary...

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