RE:RE:RE:Theralase = TLD-1433fredgoodwinson wrote: Oilminer/Enrique - yes they must be trying to get those 5 re-treated as soon as feasible as until at least 90 days` after the last of these second treatments and despite no deficiency in the compound itself TLD-1433 will be unfairly blighted by the deficiencies of the initial dosing and activation.
Would hope that they really have got a handle on the dosing but as you say we thought that at the end of Phase IB. They must though that think they`ve solved it as there`s really nowhere to hide now. If these 5 aren`t good then they`ve obviously not solved the problem of treating the individually variable integrated spheres that are bladders and the terial is effectively over but actually don`t think it`s that serious -just really puzzling. The built-in safety (steep gradient and zero uptake in healthy urothelium) likely gave them leeway to moderately over-treat but instead they have hugely under-treated with very negative short-term consequences for the Company.in some ways they couldn`t have sabotaged things better if they`d tried and were only saved from more serious consequences by Covid and the prevarication of the FDA.
The under-treatment was universal and at both sites which suggests correct implementation of an incorrect treatment protocol rather than incorrect implementation of a correct treament protocol.Was it really down to the pharmacist? - don`t think so. There could not have been a more critical imperative than that this be got right. How did it go so wrong?
Fred and others,
We certainly lucked out that TLT desided to design study 2 with two treatments. This way they will get a second chance with many of this first batch. And, if it still needs some fine tuning, with future batches.