RE:About the addition of up to 9 CSS ... SF wrote:
"These "up to 9 new sites" could also be because the FDA wants 125 patients, instead of only 100, considering the 12 undertreated patients, in order to have a better picture. But even there, even with these 12 undertreated patients, we already have excellent numbers (28% CR and 38% TR), despite them representing 41% of our 29 evaluable patients (12 NR out of 29 evaluable patients)."
I believe the FDA would want a more representative sample of patients treated (i.e. a total of 125), especially considering 10% of this total will have been undertreated.
When looking at the durable response numbers in those Ph 2 patients who received "two optimized" treatments (patient 13 & on), the 450 day CR is 35%. If you add in the two Ph 1 patients who received a single optimized treatment, the 450d CR rises to 47%.
The above suggests that optimization helps, but hypothetically, more treatments may not always translate into better outcomes across the board. Imo, the key for any successful treatment is to pack a big punch at the beginning, which our ACT attempts to do at the molecular level & is thus far doing relatively well...multiple weaker/ineffective punches (or too many of the same punches) could not only potentially lead to more side effects, but also more treatment resistance (I.e. a weaker punch(es) can unintentionally encourage the growth of more resistant cancer cells). You can see this resistance happening repeatedly in oncology wherein a highly-focused treatment attacks a single target/checkpoint. When such a highly-targeted treatment is performed over & over & over again, such a serial approach may actually promote a more aggressive cancer & metastasis.
The big reason I invested in this tech is because TLT is approaching cancer treatment from a more universal (a one mechanism fits all) perspective. And in those cases where more is needed, you can combine the better/best option with the lesser one...all imo.
I am still thinking the 9 new sites in "2023" has some connection with a friendly partner/funding...& possibly grant help. There is "a lot" of pressure at both federal & state levels for the FDA to perform its obligation in providing the public not only safe & effective treatment options in a timely manner, but also optioms that are both patient & pocket book friendly. This is only a matter of time in my analysis...