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VERSION:2.0
PRODID:-//ORION Biotech Catalyst Calendar//company//EN
CALSCALE:GREGORIAN
X-WR-CALNAME:ORION — PYPD stated timing
X-WR-CALDESC:Exact dates PYPD stated in SEC filings\, quoted as written\, w
 ith SEC links. No forecasts.
REFRESH-INTERVAL;VALUE=DURATION:PT12H
X-PUBLISHED-TTL:PT12H
BEGIN:VEVENT
UID:orion-event-FDA20261030-PYPD-FDA-DECISION@orionbiotechai.com
SEQUENCE:2
DTSTAMP:20261029T000000Z
LAST-MODIFIED:20261029T000000Z
DTSTART;VALUE=DATE:20261128
DTEND;VALUE=DATE:20261129
SUMMARY:PYPD D-PLEX100: FDA decision\, “November 28\, 2026”
DESCRIPTION:PolyPid Ltd. (PYPD)\, D-PLEX100: PDUFA target action date.\nCom
 pany wording\, as written: “PolyPid’s management will also review the 
 Company’s plans to maximize the value of D-PLEX₁₀₀\, for which a N
 ew Drug Application (“NDA”) is under FDA Priority Review with a PDUFA 
 goal date of November 28\, 2026\, including potential label expansion beyo
 nd colorectal surgery and potential geographic expansion.”\nStated perio
 d: “November 28\, 2026”.\nFiled 2026-10-28\, SEC Form 6-K\, EX-99.1.\n
 SEC filing: https://www.sec.gov/Archives/edgar/data/1611842/00012139002611
 3107/ea030979101ex99-1.htm\nORION page: https://www.orionbiotechai.com/com
 pany/PYPD?src=ics\nORION records what the company wrote. It is not a forec
 ast.
URL:https://www.orionbiotechai.com/company/PYPD?src=ics
TRANSP:TRANSPARENT
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