RE:RE:RE:RE:RE:RE:RE:RE:RE:AGMThanks for sharing your AGM info Jaro1977.
If the 450-days data (durable response) on the first 25 patients is to be above competition, this will lead them to
FDA Breakthrough designation. The FDA has no choice. And it's the
Accelerated Approval program that would allow them to obtain revenues for the remaining patients to be enrolled.
Considering that COVID-19 is not going away, that in Europe and the US, the 7th wave is already buillding, TLT will probably opt for a JV if this 7th wave is to clog the system once again as reaching the target of 100-125 would take too long. TLT is entitled to have up to 15 CSS (we have 12 now). Opening 3 more CSS (clinical study sites) would take time, would incure additional costs but if we qualify for the AA program, revenues could reduce this burden. But clearly, a JV would bring an upfront payment that could be used to avoid a pp, help start the NSCLC Ph. 1b, fund the COVID-19 vaccine, etc ...
In the meantime, the best visibility be the 270-days data that will come from the August 31 MD&A at the latest as we will have the data of 11 patients that were pending status on May 30 after having received their 2nd dose (@180-days). This is when we'll get a clearer picture of what the optimized pool of patients can deliver at 60% (270/450 = 60%) into their way to a durable response milestone (450-days). It will be very interesting to see these % of efficacy at 270-days.
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Jaro1977 - (6/29/2022 12:31:54 PM)
RE:RE:RE:RE:RE:RE:RE:RE:AGM
They are focused on finishing the NMIBC phase 2 and BTD, AA
It's possible that they could commercialize 2023 while the phase 2 is still going on towards patients 41-125 with good data and talks with FDA
I do not recall the exact words but it seems that they would look at a partnership, JV if it were to come along but that they really want to finish the trail and showcase excellent results. They know what they have and it could be so much more than what is is at now once it's proven.