u/rman712

▲ 2 r/govcon

8(a) set-asides are clustering hard around two NAICS codes this month. Anyone else seeing this?

Been tracking new 8(a) solicitations daily for the last month and noticed something weird: of ~140 active 8(a) notices right now, 23 are in NAICS 541512 (computer systems design) and 19 in 541611 (admin/management consulting). That's ~30% of the active pool in two codes.

Expected construction and facilities (236220, 561210) to dominate the way they usually do in small business spend. Those are way down like 8 and 6 notices respectively.

Two things I can't tell:

  1. Is this a real shift in agency demand toward IT/consulting set-asides, or is the construction work getting routed through HUBZone and SDVOSB and just not hitting the 8(a) feed?

  2. Anyone in 541512 or 541611 actually seeing more agencies reach out this month, or is this just a SAM.gov reporting quirk?

Response deadlines also feel compressed. 40% have due dates within 21 days, which is short for anything substantial.

Y'all seeing the same?

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u/rman712 — 8 days ago
▲ 30 r/drugdevelopment+1 crossposts

Been building a working file of upcoming FDA catalysts and figured I'd share. 13 PDUFA dates through September plus the 3 confirmed AdCom meetings I've got on deck. All drawn from company press releases, Federal Register notices, and STAT/Endpoints coverage. let me know if you spot anything missing or off.

PDUFA dates (US-listed sponsors)

Date Ticker Drug Indication Pathway Severity
May 29 MNKD Afrezza (inhaled insulin) Pediatric T1D/T2D sBLA Medium
May 31 ONC sonrotoclax r/r MCL post-BTKi NDA, priority High
Jun 2 AZN Datroway (datopotamab deruxtecan) 1L mTNBC sBLA, priority High
Jun 5 ARVN vepdegestrant (ARV-471) ESR1-mutated ER+/HER2- BC NDA High
Jun 20 ACHV cytisinicline Smoking cessation NDA, breakthrough High
Jun 29 LNTH Ga-68 edotreotide kit NET PET imaging NDA (PDUFA extended 3mo) Medium
Jun 29 PFE HYMPAVZI (marstacimab) Hemophilia inhibitor + pediatric sBLA, priority Medium
Jun 29 ARQT ZORYVE (roflumilast) 0.3% cream Plaque psoriasis, ages 2-5 sNDA Medium
Jul 6 ORKA Orca-T AML/ALL/MDS requiring alloHSCT BLA, priority (3mo extension) High
Aug 22 CAPR deramiocel DMD cardiomyopathy BLA Class 2 resubmission High
Aug 30 PHA Besremi (ropeginterferon alfa-2b) Essential thrombocythemia sBLA Medium
Sep 18 NUVL zidesamtinib TKI pre-treated ROS1+ NSCLC NDA, breakthrough High
Sep 22 IONS zilganersen Alexander disease NDA, priority High

Upcoming AdComs

Apr 30 — ODAC (AstraZeneca, AZN) — back-to-back sessions:

  • Morning: camizestrant + CDK4/6i for HR+/HER2- BC upon ESR1 emergence (SERENA-6 data)
  • Afternoon: Truqap + abiraterone for PTEN-deficient mHSPC (CAPItello-281)

This is the first drug-related AdCom in ~9 months. Panel is going to be fresh, which cuts both ways.

Jul 23-24 — Pharmacy Compounding AC — bulk drug substance list review. No
public-company sponsor.

A few I'm still hunting for specific dates on:

  • AstraZeneca baxdrostat (hypertension, first-in-class aldosterone synthase inhibitor) — Q2 2026 via priority review voucher, no calendar date publicly disclosed last I checked
  • Anything hitting in late June / early July I might have missed

If you're tracking any of these or know of others that should be on here, drop them in the comments and I'll keep this updated. Happy to share the maintained version
directly with anyone who DMs. I just don't want to turn a Reddit post into a link
dump.

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u/rman712 — 29 days ago