RE:RE:RE:Safety is more important...Thanks StevenBirch & Socksblonds642 for responding to my post...
For clarification purpose, what I am trying to explain in my post, is that it is not TLT that decide what is safe or not in the phase11 trial...It is 100% the FDA.
Socksblond642 you are correct, from the start of the phase11 trial the efficacy numbers have been steadily increasing, so efficacy was not a good enough reason for the FDA asking for clarifications. It had to be something more important than efficacy, and an increase in the ''serious adverse events'' seem to be more of a good reason for the FDA asking for clarifications.
As I said in my post the good new is, that TLT with the help of Dr.Jeweet is looking for new patients, it is a very good indication that TLT is 100% convinced that the ''serious adverse events'' are not related to the trial treatment(Ruvidar). And TLT is back on track with the trial.
Which is a great thing.
As for the Advisory Board Meeting, StevenBirch you are correct it would be nice...but don't count on it...the questions answered in those meeting are never on touchy subjects and safety is a touchy subject.
StevenBirch wrote: But they state "no SAEs directly associated with the Study Drug or Study Device, therefore, the Theralase technology presents a safe, effective alternative therapy for patients".
Doesn't that sound like it's been looked at and ruled out? And that maybe it's more of a patient screening question?
Hopefully these Advisory Board Meetings shed some light on this and other questions, it certainly seems like that is the intent and is a good thing.
wildbird1 wrote: Lets recapitulate here...
There is 5 grades of severity of serious adverse events.
1=Mild.
2=Moderate.
3=Severe.
4=Life treatening.
5=Death.
Lets take the no3(severe) and no4(life treatening).
In Aug 29,2023, there was 3 grade3(severe) and 2 grade4(life treatening) for a total of 5 severe to life treatening adverse events reported.
In March27,2024there was 7 grade3(severe) and 3 grade4(life treatening) for a total of 10 severe to life treatening events reported in just a few months.
An increase of 100% in severe to life treatening serious adverse events in just a few months.
And what people on this board are saying(except BigKahuna57) is that the FDA should not investigate more thouroughly a 100% increase in severe to life treatening serious adverse events, just because TLT(not the FDA) is saying that the serious adverse events are not related to the study11 treatment(Ruvidar).
Wow!
Mabe people on this board are correct and the FDA doesn't care enough about the safety of a patient in a clinical trial to ask TLT to double check a 100% increase in severe to life treatening serious adverse events numbers.
wildbird1 wrote: In Aug 2023, the FDA asked TLT for extra data clarifications. We all did assume(including me) that it was the 450 days efficacy data that the FDA wanted.
After reading the last update March 27,2024 ... there is a very big chance that there was a more justifiable reason for the FDA asking TLT for more data clarifications.
In the Aug 2023 PressRelease TLT said '' For 60 patients treated in study11, there have been 9 '' serious adverse events'' reported.
9/60 = 15% of patients treated.
In the last update March 27,2024 TLT said'' For 64 patients treated, there have been 13 ''serious adverse events''.
13/64 = 22% of patients treated.
In Aug 2023 the FDA must have noticed a steady increase in the '' serious adverse events'' data.
The increase although it was not alarming, it was worth asking TLT to double check the ''serious adverse events'' data''.
The FDA asking TLT to double check the ''serious adverse events'' data is very legitimate, after all the appointmnent to the Data Safety Monitoring Board(DSMB) are made by the study11 sponsor(TLT is financing the DSMB).
In short...
There is nothing of grave concern here, the FDA is simply doing its job by asking TLT to double check its own ''serious adverse events'' data to make sure that the increase is not related to the study11 treatment drug(Ruvidar).
Question?
Why is the ''serious adverse events'' % increasing?
The answer could be in the the last Corporate Presentation(03,19,2024) page 14...under '' previous BCG therapy treatments''.
It is said '' 21% of patients have received over 19 BCG treatments''.
A patient that has received over 19 BCG treatments is usually an older patients who is in really bad shape and also a patient who is almost untreatable.
Note: 21% of patients with over 19 BCG treatments, is very close to the 22% of ''serious adverse events''( coincidence maybe not).
You have to give credit to TLT for treating older patients that nobody else want to treat,TLT could have simply placed these patients on its exclusion criterias list, and the CR% would have increased accordingly.
Now the good news...
As we speak TLT must have double checked most of the CSS(Clinical Study Sites) data and came to the conclusion that the data submitted to the FDA on '' serious adverse events'' were accurate and all ''serious adverse events'' were unrelated to the study11 drug(Ruvidar).
Why???
In Aug 2023 the hiring of new patients came almost to a complete stop, lately Dr.Jewett came on board specifically to help increasing enrollement of new patients, indicating that everything is back on track.
Extra notes;
1) If something goes wrong with safety(serious adverse events) after the BTD approval, it is the FDA that will take the blame for the early BTD approval.
2) Checking the 450 days efficacy data is simply a logical step not related to the BTD approval. The 450 days efficacy data will be very important for the phase11 final clinical data(2026), and when TLT will try to become the standard of care.
3) My post is strickly based on the fact that for me, safety is more important than efficacy when the FDA give early BTD approval.
Why???
-A low efficacy doesn't kill a patient, it simply doesn't cure the patient.
-But ''serious adverse events'' could kill a patient if left unchecked".
For now, up to 40% efficacy and 100% safe.
BTD approval is in the bag.
(you already knew that).