secwatch.observer — SEC 8-K summary
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Issuer:     Processa Pharmaceuticals, Inc. (PCSA)
CIK:        0001533743
Form:       8-K
Filed at:   2023-12-19T23:59:59+00:00
Accession:  0001493152-23-045362
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Processa Pharma: Phase 1b interim data show NGC-Cap improved safety with 10x higher 5-FU exposure than capecitabine
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- NGC-Cap doses: 75-225 mg twice daily vs capecitabine's 1600-2500 mg twice daily; 5-FU exposure up to 10x greater.
- Anabolite side effect profile similar to capecitabine; FBAL-related side effects (hand-foot syndrome) almost absent; FBAL exposure ~1% of capecitabine.
- FDA acknowledges NGC-Cap as a New Chemical Entity based on altered metabolism and distribution of 5-FU.
- Fireside chat scheduled Dec 20 at 4:30 PM ET to discuss data and corporate strategy; results require further studies.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1533743/000149315223045362/0001493152-23-045362-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1533743/000149315223045362/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-045362

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