Amendments to Approved Protocols

Other day, while sitting in Court, I observed Company Bench of High Court was not comfortable to allow amendment to the Original Scheme without convening another meeting for Shareholders approval. In a similar matter, we were able to get through an amendment in the Scheme of Merger/Arrangement approved by a shareholders' meeting without holding another general meeting. We annexed NOCs from all existing shareholders with the amendment so as to satisfy the Court. If the amendments are minor, clarificatory, or administrative and do not affect the fundamental terms of the scheme, courts are likely to allow changes without requiring a new meeting. However, if the changes significantly alter shareholders' rights, entitlements, or obligations, courts may insist on a fresh shareholders' meeting for approval. The Court exercises discretion to determine whether convening another meeting is necessary for procedural fairness and stakeholder protection. If the court is satisfied that the amendment is in the interest of all stakeholders and does not fundamentally change the scheme, it may waive the requirement for a new meeting.

There are hidden costs of protocol amendments. Clinical trials rarely run exactly as planned. Adjustments happen but some come at a steep cost. On average, a single protocol amendment adds 3+ months to a trial and can cost over $500,000 depending on the size of the trial. Why? 🔹️Protocol updates take time, and if outsourced, they cost. 🔹️Regulatory submissions and approvals add layers of complexity. 🔹️Informed Consent Forms (ICFs) must be updated, then submitted to IRBs/Ethics for approval. 🔹️Once approved, sites must implement the changes—requiring re-training, new documents, and operational shifts. ➡️ Every step costs money and delays progress. Every amendment isn’t just a delay. It’s a cost to sponsors and lost time for patients. #ClinicalTrials #DrugDevelopment #ClinicalOperations #Biotech