72% CR at any point in time.First let's do a quick recap...
In the May 28,2021 Pressrelease TLT said " Study11 has a primary endpoint of Efficacy defined by " CR at any point in time".
In order to define the CR at any point in time, we have to use the Swimmer Plot numbers provided by TLT.
Nov,2022, Swimmer Plot & April,2023, Swimmer Plot.
In the Nov,2022 Swimmer Plot, the CR numbers at any point in time for the first 43 patients are as follow...
23 patients at 90 days.
1 " at 180 days.
2 " at 270 days.
Total 26/43 patients= 60% CR at any point in time.
Note: The above 60%CR was validated by TLT in the Nov 29,2022 Pressrelease.
Before we continue...Let's be clear on something, when TLT will apply for BTD,TLT will use only the latest updated Swimmer Plot numbers.
For now only the April,2023 Swimmer Plot numbers are permitted to be used to define the CR% at any point in time(efficacy).
In order to make a direct comparison with the Nov,2022 Swimmer Plot, I will use the first 43 patients in the April,2023 Swimmer PLot.
The CR% numbers at any point in time for the first 43 patients in the April,2023 Swimmer Plot are as follow...
27 Patients at 90 days.
2 " at 180 days.
2 " at 270 days.
Total 31/43 patients =72% CR at any point in time.
Note: All the above numbers are exactly as they are in the 2 Swimmer Plot provided by TLT.
The CR% at any point in time for the first 43 patients, went from 60%CR(Nov,2022), to 72%CR(April,2023), an increase of 20% in the last 5 months.
72% CR is also 10% higher than the 66% CR at any point in time of the phase1b trial.
Note: If you remember the FDA did like the 66%CR of the Phase1b trial (2Q2020 Newsletter).
With 100% safety and 72%CR at any point in time (and increasing) the FDA will have no choice but to seriously consider giving TLT BTD and or AA.
By waiting for the Q1,2023 strong efficacy data to apply for BTD, TLT is now in a position to force the hand of the FDA.
Note: Just in case somebody ask, the CR% at any point in time for the first 25 patients in the April,2023 Swimmer Plot is 76%CR.
Note: Although not in play for now, the 450 days durations %numbers looks very promising.
To conclude...
My precious TLT shares are staying with me.