RE:RE:RE:RE:RE:3rd quarter Thanks Eoganacht..excellent post.
Although R.White did find unusual the request for more central pathology data, at the same time R.White must have felt relieved and said to himself...
Woow!!! That is all the FDA is asking for!!!(TLT Scientific Team Dr.Mandel &Co know that the pathology concordance is very high).
By not asking TLT for something more complicated than double-checking TLT-Ruvidar data, we can easily say that the FDA has painted itself into a corner, and once TLT has compiled the data clarifications, the FDA will have no choice but to give TLT-Ruvidar Pre-BTD & BTD approval.
Pre-BTD & BTD approval are much closer than we think.
You have to love your TLT shares.
Eoganacht wrote: It's clearly not a concern as far as Roger is concerned.
"...it was a bit of a surprise for us that they insisted on central pathology. Because the concordance level of local pathology compared to central pathology is extremely high - 95 to 100%. I think when I was talking to Doctor Peter Black, who runs the UBC site, he did a study for monoclonal antibody, I think Atiza was the drug. And his concordance on his 120 patients was 100% across the board.
Why? Because in local pathology, you have board certified pathologists reviewing the data. They're experts in their field. You're now going to take the slides that they're looking at and give it to another board certified pathologist who also is an expert in their field. The amount of time that these two men or women disagree with each other is virtually zero because they wouldn't - they would say we don't have enough data or this is cancer or it's not. Because they're making decisions on patients' lives...whether you're cancer free and that's not a problem, or we think you've got cancer and you should have your bladder removed. Because there's a 12% morbidity and I think almost a 14% mortality risk from the surgery from radical cystectomy. So these decisions aren't made easily.
I think it was a bit of a weird ask because the concordance is extremely high. You can imagine if you go to your doctor and he says "yes, you have cancer", and you go to another guy and he says, "no, no, no, you're perfect". That's probably not going to happen.
So it was a bit of a weird ask, but they are the rulemakers. They're the judge, jury and executioner for where we want to go. Because the ultimate goal is FDA approval. Because you want access to the US market. They're the gatekeepers. So you're going to have to comply with what they say."
plantrader wrote: Right now IMO one concern is that the "central pathology" analysis finds inconsistencies in how the tissue or data was analyzed previously as part of the results the company has been publishing thus far. Since we don't know exactly why the FDA appears to have added that requirement mid-stream, I think it's a legit concern. Receiving BTD will relieve all those types of ambiguous concerns based on lack of info.