RE:RE:the protocol change notice from Health CanadaN0taP00p wrote: This was a great discussion indeed.
1. Optimistic Path - No delay to pre-BTD submission, despite additional post 450 day CR data needs. Work with the FDA to add HCA-approved mods into the remaining portion of phase 2. No sad violins here. Yet. This is what we all want.
2. Most likely path? Based on TLT past performance, will push pre-BTD submission out 6 to 9 months to account for Post-450 day CR data collection (for a statistically significant number of CR patients at say, 6 months after 450 day CR), with central lab validation of said data.
I am assuming the company offered up to date transparency on the new corporate presentation as part of the current offering, where BTD is still projected for Q4 23/Q1 24. Considering this revised corp presentation is a key part of their pitch to new investors, the very last thing they would want to do is mislead them right from the start.
In terms of the extension of the 450 day monitoring, I think the 18 month clinical target is the primary metric they're after, which is just an additional 90 days.