Much better data today than one year ago...The Secondary Objective(Duration Of Response%), is a very important data when a company(TLT) apply for the FDA Pre-BTD & BTD approval.
One year ago (Pressrelease 29.Aug.2023), when the FDA asked TLT to double check its +450 days data, the Secondary Objective(Duration of Response%) was at 33%.
In the last Pressrelease(12.Aug.2024) the Secondary Objective%(Duration of Response) has increased to 44%.
The big increase in Secondary Objective(Duration of Response%) from 33 to 44% could be attributed to...
Doctors are getting better at fine-tuning the treatment for the specificity of each patient, or it could be attributed to the extra treatments the patients are receiving, or it could be attributed to the parameter of the data collected that have changed, or all the above.
Whether it is the fine-tuning, the extra treatments, the parameters, it doesn't matter, one year ago when TLT made the first attemp at Pre-BTD approval, the Duration Of Response was at 33%, now it is at 44%.
According to TLT, the Pre-BTD application has not been file yet, as TLT is still receiving clinical data from the CSS, according to Dr.A.Mandel the data received so far are world class.
Question?
What are the chance the FDA will give the Pre-BTD approval the next time TLT file a request?
Lets answer that question with another question?
How can the FDA refuse to give TLT Pre-BTD approval for a treatment(TLT-Ruvidar) that has much better short term and long term data today than one year ago?
In short tha FDA Pre-BTD and BTD approval are in the bag.
Note: The number of shares traded...
The puny little number of shares traded after the last PressRelease(12.Aug. 2024) indicate that 99.99???% of the shares are still in the hands of the longs, they know the best has yet to come.
Hold on to your TLT shares.