RE:Uncharted Territory...Complementary Note:
The FDA time-line for the approval of a drug is 12-15 years after the completion of animal toxicity tests.
TLT animal toxicity tests were completed in 2014, and 12-15 years is for a drug with a MOA(Mechanism Of Action) that the FDA has seen before.
TLT New PDC compound has a MOA(Mechanism Of Action) that the FDA has never before evaluated in a phase11 trial.
For a completely new and innovative PDC compound like TLT-Ruvidar, the FDA approval time-line could easily be over 15-20 years.
In conclusion:
In regard to approval time-line TLT management has done an incredible job so far with a very little budget(compare to Big Pharma budget).
And as we speak TLT is on the verge of providing the FDA with all the necessary data for Pre-BTD and BTD approval(few weeks).
Thank you to TLT management for this incredible achievement.
wildbird1 wrote: I stongly beleive that TLT-Ruvidar BTD approval is being held-back by the fact that having a new PDC treatment halfway through a FDA phase11 trial is a first for the FDA.
The FDA is almost in uncharted Territory(that could explain the FDA asking for more data and clarifications).
I also beleive that the FDA is working hard with TLT to advance this new TLT-Ruvidar treatment.
Why?
Because the FDA gave TLT FTD(Fast Track Designation).
FTD is for unmet medical needs.
The unmet medical need is that no other FDA approved treatments for NMIBC, treat the same difficults type of patients as TLT-Ruvidar(older and heavily pre-treated patients), and is 100% safe.
In short the FDA badly need TLT-Ruvidar.
The fact that the FDA badly need TLT-Ruvidar doesn't mean that the FDA is going to skip a few steps in its BTD safety evaluation protocol, just to give TLT-Ruvidar BTD approval.
No! It doesn't matter how good TLT-Ruvidar CR data are, TLT-Ruvidar has to follow the FDA BTD evaluation protocol.
In short...If a company(TLT) comes up to the FDA with a new and advanced way to treat cancer, this company(TLT) better be ready to answer tough questions from the FDA.
Note 1):
TLT-Ruvidar ignored buy the market???
The market is very concervative, the market doesn't bet on products from small cap company that have not been proven, BTD approval will rectify that situation.
Note 2):
Financing.
The goal is to get enough money to get BTD approval.
How close TLT is to get BTD approval?
To answer that question, we only have some pionters.
-In the May 30,2024 Pressrelease... TLT has commenced to receive the data that the FDA need for the Pre-BTD approval, and the data received are positive with some patients being cancer free for up to 3 years.
-Lately R.Dumoulin must have received more of the remaining data, and the data must also be positive, that could explain why R.Dumoulin said '' We are close to realizing it's value'' ('' Value'' could mean BTD approval).
For now we wait for the remaining data, it is not like these data were years away.
The data have commenced to come in one month ago, the rest of the data could be just a few weeks away(or lesss).
Can you smell Pre-BTD and BTD approval.