I’ve learned from experience not to regard information on the clinical trials website as the most accurate or updated information. What the company has repeatedly stated is more reliable. Hence, I’m anticipating this trial will stop at 120 patients.
As everyone knows, there has been discussion by Swami about the possibility of speeding up the progress of this trial.
One possibility Swami mentioned was the conversion of interim analyses. Sixty patients would have been enrolled by August last year. Might it be possible to submit a PMA based on the post-12 month assessment data from the first 60 patients, perhaps supplemented with RWE data (another option mentioned by Swami) in severe burns?
Ann: Macquarie Australia Conference - Presentation, page-48
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