Theralase Technologies Inc. V.TLT

Leap Frogging Competition?

[Kingpin68]

With Sesen Bio reeling from the Complete Response Letter (CRL) (issues identified) from the FDA, does Theralase have any real competition right now ? Sesen's Biologics License Application (BLA) for the Companys lead program, Vicineum for the treatment NMIBC was not approved. SESEN may have to do another 100 patient trial, and from what I understand, their 12 month data was about the same as Keytruda, which is to say, not great, and a low bar for TLT to beat if results continue to trend the way they are. Once Theralase gets Breakthrough Designation, the competition is in trouble, even further, IMHO.

[Oilminerdeluxe]

Let's have a few million shares traded today as well.

[Rumpl3StiltSkin]

Well, there was that NMIBC drug out of the UK that many here were discussing a few years back. I forget the details but I think the CR % was around 45. So not bad for a drug that someone could just take. We'd all like TLT's NMIBC tratment to eventually supplant the current stadard of care. That will take a while and it is likley that this UK drug will at least be part of the competition

[Kingpin68]

Wow, a CR of 45%, from a pill, from an unknown drug from an unknown company maybe in the UK. Sounds impressive.

[Rumpl3StiltSkin]

A shot actually, but yeah. by the time they are here and FDA approved TLT will likely be on to GBM or NSCLC or both.

[CancerSlayer]

  There certainly is no "in-class" competition, & fortunately there's very little competition from out-of-class treatments, except for N-803 (by ImmunityBio) used in combination with BCG, which is also looking at N-803 alone in CIS disease.  The combo treatment did meet its primary endpoint at a 72% CR rate with some expected fall-off after that...more complete