RE: Stable sp but now wonder about a top up placing at 10p... again!14 Oct 2025 18:31
Evening Damion - re your statement, "...how many investors even realise that changing the formulation to improve absorption automatically requires a further in human BE Study to be passed before a P2", I asked Grok Ai about this:
"Whether a reformulated drug requires another Phase 1 trial after completing an initial Phase 1 trial depends on the nature and extent of the reformulation, as well as regulatory requirements. Here’s a concise explanation:
Minor Reformulation: If the reformulation involves minor changes (e.g., adjusting excipients, dosage form, or manufacturing process) that do not significantly alter the drug’s pharmacokinetics (absorption, distribution, metabolism, excretion) or safety profile, a full repeat of a Phase 1 trial may not be necessary. Instead, bridging studies (e.g., bioequivalence or pharmacokinetic studies) might suffice to confirm that the reformulated drug behaves similarly to the original formulation.
Significant Reformulation: If the reformulation substantially changes the drug’s properties—such as altering the active ingredient’s release profile, bioavailability, or potential toxicity (e.g., changing from oral to injectable or modifying the chemical structure)—regulatory agencies like the FDA or EMA may require a new Phase 1 trial. This is to re-evaluate the safety, tolerability, and pharmacokinetics of the reformulated drug in healthy volunteers.
Regulatory Guidance: Regulatory agencies assess reformulations case-by-case. For example, the FDA’s guidance on bioavailability and bioequivalence studies (21 CFR 320) or the ICH M3(R2) guidelines on nonclinical safety studies may dictate whether additional Phase 1 studies are needed. If the reformulation introduces new risks or uncertainties, regulators may mandate repeating Phase 1 or conducting additional nonclinical (e.g., extended toxicity) studies before proceeding.
Extended Toxicity Trials: Before extended toxicity trials (typically nonclinical studies in animals), the reformulation’s impact on toxicity must be understood. If the reformulation changes the drug’s safety profile, additional nonclinical data may be required, and this could influence the need for a new Phase 1 trial to confirm human safety.
In practice, sponsors consult with regulatory agencies (e.g., via pre-IND meetings or equivalent) to determine the necessary studies. For minor changes, bridging studies are often sufficient; for major changes, a new Phase 1 trial is more likely."
I'm sure JR knows what he's doing and the ramifications of making any significant changes.
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