Theralase Technologies Inc. V.TLT

The BTD thing

[Oilminerdeluxe]

So, when might this be given realistically?

[robertshaw]

maybe 2 months later, we will get it.only God knows...

[Oilminerdeluxe]

Do we need like 25 patients done at 15 months or so was what my feeble mind was supposed to write. Or can the BTD be given at any time? I suspect this has been debated but I can't rememeber what was said then. I have to say I feel very happy about this. Relieved and very hopeful about the future. Financings should not be a problem going forward. (Better unjinx that one). This simply must be

[CancerSlayer]

Last post all imo. Hey oilminer...if the optimized CR rates continue to look good in the 7 pending patients, I think a BTD app could be filed.  There is no need to wait for durable/360+ day data on any specific or minimum number of optimized patients....as BTDs are generally awarded based on a primary/clinically significant endpoint (I.e. CR rate).  All imo.

[Oilminerdeluxe]

CancerSlayer, thank you. Looking good. After all these years. Some nice positive momentum.

[Rumpl3StiltSkin]

All I have to add to this topic, is that from my reading and understanding, FT or BT, either one will lead to Accelerated Approval(commercialization) IF the durable CR data supports it after the 450days or so that the FDA has specd for TLT. Like Slayer said BT designation could be an upgrade to the current FT if the 90day CR %s continue at this rate, or improve. That could happen any time, I

[Pandora]

Posted this a couple of days ago but will run it through again -- maybe it does not answer any questions: Info only - picked up off another board: - breakthrough therapy designation is requested by the drug company. If a sponsor has not yet requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if (1) after reviewing submitted data and

[Oilminerdeluxe]

Thanks Pandora.