Theralase Technologies Inc. V.TLT

FDA taking a year for IBRX review

[N0taP00p]

Doesn't Immunity Bio have BTD already? If their biologics application can take almost a year to get approved, why would Theralase's go any faster? I know there's no BCG involved and fewer treatments. But still, wondering. Health Canada is not even on the radar.

[ScienceFirst]

I documented the differences recently.

[Rumpl3StiltSkin]

Yep, Since this Phase 2 is Pivotal, TLT should have Accelerated Approval in mid 2023.

[FGPstock]

Ben, i guess our definition of "receive" is differnt. in my world, "receive" means TLT gets or is granted BTD. I guess you difine receive as "apply". Not sure why you mention meeting with fda aug/sep 2022, they way i read it is that is when TLT applies for BTD, its so obvious, .lol... ScienceFirst (7725) User Actions   May 31, 2022 - 03:36 PM 135 Reads

[ScienceFirst]

FGPStock ... If you had taken the time to look at the Feb. 2022 corporate presentation (which obviously you didn't considering your questioning about the pp), you would have understood in a wink where do the Breakthrough designation application could start.  It's all there for you. But instead of consulting it, and because you had a hard time understanding where it would fit on the

[FGPstock]

do you know the definaition of "receive"? RE:When push comes to shove... Eoganacht ... Everything matches with the updated corporate presentation of Feb. 7 where they expect to receive a Breakthrough designation around November/December.

[ScienceFirst]

Do you know the definition of "definaition" If you had consulted the corporate presentation instead of being insecure and start discussions on why a po ... ____________   FGPstock - (11/11/2022 3:24:58 PM) RE:RE:RE:RE:FDA taking a year for IBRX review do you know the definaition of "receive"?

[ScienceFirst]

 Do you know the definition of "definaition" If you had consulted the corporate presentation instead of being insecure and start discussions on why a pp ... ____________   FGPstock - (11/11/2022 3:24:58 PM) RE:RE:RE:RE:FDA taking a year for IBRX review do you know the definaition of "receive"?