RE: Email sent to FDA20 Feb 2026 09:29
For the skeptics who are still debating on the email, the chap has just given a generic response and gone to the effort to respond. Not sure why everyone is making a mountain out of a molehill, read below for absolute proof copy and paste, the level of trust here is abysmal.
Good morning,
OOPD cannot provide status updates on submissions under review by the Agency. Please note that staffing changes at the beginning of 2025 have impacted our ability to maintain our internal policy for 90-day reviews. We ask for your patience as our office continues to review applications as fast as is accurately possible.
Kind regards,
Corey
Corey Burns, MPH
Project Management Officer
Office of Orphan Products Development
U.S. Food and Drug Administration
(240) 402-4036
orphan@fda.hhs.gov
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Sent: Thursday, February 19, 2026 4:09 AM
To: OPDAR <OPDAR@fda.hhs.gov>
Subject: [EXTERNAL] Fwd: NXP002 (inhaled tranilast) for IPF URGENT
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe.