RE:RE:Pioneering is never easy...Whatever floats your boat, Maxi. Just keep one finger free to plug any holes in the boat. Quoting Google search results is not going to help you with this investment. Cell death is cell death and measured as an endpoint result, regardless of the PDT type. To reiterate, it would help to know what exactly is holding up pre-BTD submission for this PDT. Work on that angle if you can.
Maxcitrac wrote: Nice post Wild...
NotaPoop,he is one of the Michael.B DumDum minion that Wild... talk about in his post.
NotaPoop mention that PDT is not new to the FDA.
Yes, but the mechanism of action of Ruvidar PDT treatment is new to the FDA.
Photofrin mechanism of action is Ischemic Necrosis.
Ruvidar mechanism of action is Immunogenic Cell Death.
There is a difference between these two mechanism of action.
Wildbird is right the FDA has never before encounter a PDT treatment like Ruvidar and like Wild said the FDA has never before been asked to grant BTD to a PDT treatment.
wildbird1 wrote: The real problem right now, is not the FDA or TLT management, the real problem is the innovative aspect of this new treatment.
The FDA has never before been asked to grant BTD to such an innovative PDT treatment.
You have to remember that when granting early BTD approval, the FDA has to be very carefull not to make any mistakes that could endanger future patients safety.
As we speak the FDA has no preceding references to judge this new PDT treatment, the only option that the FDA has to evaluate this new treatment is to analyse as much data as possible.
That is why TLT has to provide the FDA with the full set of data that the FDA requested in the first place in 2023, + the FDA request for post study11 monitoring of response.
On a more positive note...
In the last update 27 Nov 2024...
TLT said'' TLT has received the majority of the clinical data from the CSSs, with a high percentage of patients showing a duration of their CR beyond 450 days''.
The above indicate that TLT could be very close to having all the data the FDA is asking for, and the post study11 data are looking pretty good.
More positive notes...
- 43.6% of patients that responded to the treatment are still CR at 450 days.
-Keytruda...18.9% of patients that responded to the treatment are still CR at 450 days.
TLT-Ruvidar with 43.6%CR is 130% more potent than Keytruda at 450 days(Merck must freak out seeing those numbers).
-Adstiladrin...23.5% of patients that responded to the treatment are still CR at 450 days,
TLT-Ruvidar with 43.6%CR is 85% more potent than Adstiladrin at 450 days.
1) I love repeating, that Keytruda and Adstiladrin with much lower CR% data + side effects+ many restrictions, did receive the FDA BTD approval.
2) The above impressive CR% will also be used by Dr.Lbiati to negotiate some Big Pharma deals(maybe Merck).
The big SP drop...
The big SP drop was done with a very low number of shares traded, +99.6% of TLT shares didn't change hands and are still in the hands of strong believers.
Note: This SP drop is a texbook exemple on how to bring down the SP minus 30% with less than one half of 1% of the total shares out count traded in one day.
Right now TLT- Ruvidar BTD approval is being slow down by the innovativeness of this new PDT treatment, and by the FDA wanting as much data as possible to properly evaluate this new PDT treatment.
But once approved, the innovative aspect of this new PDT treatment will be a very big plus, that will push TLT to stardom.
Until then we will have to endure a low SP. At least we get to enjoy the very funny and weird bashing of this stock by Michael.B.DumDum and his minion subordinates.
Note: Nice entry point for new investors.
I still love my TLT shares.