RE:RE:RE:RE:RE:RE:Are we halted ?ScienceFirst wrote: What type of reasoning is this???
FDA approvals have to be based on data. Not on air.
It happends that we just reached 1.5 months ago the milestone (450-days data on 25 patients) that was requested by the FDA at the time of the design of the Ph. 2 trial. And that was for the BCG-Unresponsive market.
The same that want rigor are the ones that want to skip steps because they own a stock and that most of the time know nothing about the environment they invest in!!!
Our turn will come. As we have enough of superior data to deserve such approval. No plot conspiracy theories here. Just well deserved FDA approval on the merit, because our data is superior to competition and allows to give patients, one more option.
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fredgoodwinson - (1/26/2023 1:48:17 PM)
RE:RE:RE:RE:Are we halted ?
Agree WATB that this would have had approval by now if it were a US Company - probably some time ago (and first line in an early stage setting - a far bigger market).
Whether this represents stupidity on their part is another matter.
So SF,
At this point is it likely, or even possible, that TLT has applied for BTD. Or are we still likely waiting on clinicians to crunch the CR data on these first 25?