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Heres a simplified reference every PV professional should remember: Key Expedited Reporting Timelines (Calendar Days) 7 Days Fatal or Life-Threatening Serious Unexpected Adverse Reactions Initial report within 7 days Follow-up report within additional 8 days 15 Days Other Serious Unexpected Adverse Reactions Significant Safety Issues Serious cases from literature Lack of efficacy (life-saving products) Transmission of infectious agents Serious overdose/medication error (with harm) 90 Days Non-serious adverse reactions (where applicable) Important Principles Day 0 starts when minimum valid case criteria are first received Timelines are counted in calendar days Reasonable possibility of causality is sufficient When in doubt Report Pharmacovigilance is not just compliance its responsibility

Therapeutic targeting of lactate metabolism The central role of lactate in the metabolic reprogramming of the TME is well-established, acting as both a key byproduct of glycolytic metabolism and a crucial modulator of various cellular signaling networks

That says nothing about whether the resulting amount does anything

3.6.3.3 Immune modulation Long-term use of proton pump inhibitors (PPI), while effective for acid-related disorders, has been shown to alter gut microbiota composition and increase the risk of infections such as SIBO and C

Zorov DB, Juhaszova M, Sollott SJ