Theralase Technologies Inc. V.TLT

Is this the year?

[valueman1]

Many of us, myself included, are long time shareholders. Honestly can't say how long I've been invested in a position but at least 19 years. Many many false starts. Could this be a year of conclusive proof and numerous news releases to show us all what we believe to be a real cure for bladder ( et al) cancer. Anxious to see what unfolds

[chry200030]

I believe that 2022 is the year that investors will be rewarded BIG time. But don't expect the stock to be trading at this level much longer. We will close 2021 with a BANG and we see MAGIC in 2022.

[ggrellette]

Every year is the year and then we say maybe next year. For me I am tired of being strung along. 

[chry200030]

Well, finding the cure for cancer is no overnight thing. It takes many years of testing. You have to get it right.. Then there are delays like COVID. But one thing to not forget, the rewards of success are huge. TLT is close now, we see the light at the end of the tunnel. Buying here at .27 is a no-brainer. We will not see those numbers much longer. New 52-week highs next week..!!!

[valueman1]

Not sure I agree new highs next week. We'll need sustained news releases before that happens. It typically sells off gradually after news. I would love to see follow ups on news to get some momentum 

[skys1]

WOOO !!! valueman. You've been in TLT for 19 years. I thought I was bad at 9 years.

[valueman1]

Oops my bad  Typo. Should have read in at least 10 years. I need a proofreader before I send these

[Eoganacht]

My guess is we'll have definitive 360 day results for the first 25 patients by August 2022 and can apply for BTD and accelerated approval then. Since we have fast track status we should get the FDA response in 6 months - by January or February 2023. If nothing else works, FDA approval to commercialize should move the needle. "Assuming that this phase II is positive, and eradicates this

[chry200030]

FDA response takes 6 months? Meanwhile patients are dying !!!! Doesn't make sense...!!!

[Eoganacht]

An FDA standard review takes 10 months but Theralase has FTD which makes it eligible for priority review, the goal of which is for the FDA to take action on an application within 6 months.

[Rumpl3StiltSkin]

isn't BTD status een faster? Within 6 months means it could certainly be sooner. I'd be shocked if the FDA didn't respond faster to a BTDisignee?!?

[DJDawg]

My reading of the approval process lines up with Eoganacht. Yes, seems slow to us but I'm guessing underfunded agency with laborious procedures. Some things that may give hope around approvals in the future (2022 vs 2023....) - ongoing BCG shortage might move treatments into a slighly faster review category (who knows) - bladder instilled therapy are not the same degree of systemic worry as a

[Yajne]

I'm having trouble reconciling Shawn's wording in the NR with the longer timing you're suggesting Eogan. His words could easily be interpreted to mean that they will submit data on the first 25 to the FDA shortly after treating twenty five patients, maybe at 90 days post treatment.  “It is exciting to see Theralase® clear another hurdle by treating the first patient in

[StevenBirch]

I don't think it matters. When they get their 25 treated and make their submission there should be a gap up and not to the pre-financing $0.60 level because not only will the clock be set at 10 months or less won't they be starting Phase I trials on GBM and/or NSCLC? Someone stated a couple of years ago, how time flies, that most buyouts come during Phase II so with all that is going on

[Eoganacht]

It all depends on when the clinical assessment data is completed. In Theralase news releases they always talk about an "interim analysis" but they never say at what point after the treatment of patient 25 the "interim analysis" can occur. In 2018 Dr. Jewett said the FDA advised it should be done after one year. To verify this, I emailed Amelia Tudo about this in October 2019

[Oilminerdeluxe]

Perhaps depending on just how strong the numbers are, that might speed things up? Just speculation. Have a nice weekend everybody

[StevenBirch]

They did stop Phase I early and yes it was to study primarily for safety but I think it shows that there is wiggle room for the FDA to decide based on the strength of the results. As always we remain optimistic.

[Yajne]

Good points StevenB and Oilminer...I also wonder if their access to the FDA gained through the FTD could play a strong role here in the timing of FDA review of StudyII leading to BTD and AA. From the Nov 23, 2020 NR: As a Fast Track designee, Theralase® will have access to early and frequent communications with the FDA to discuss Theralase's development plans and ensure timely collection

[StevenBirch]

Yes Yajne it's funny how often, when people stay on topic, that the old news releases get quoted because we either missed something or just forgot. In your quote it shows just how involved the FDA already were. At the AGM I attended right after the disastorous financing I think they met with the FDA that very day. And in this release it says "which the FDA has previously defined to the

[Oilminerdeluxe]

Moving in to dollar terrirtory would be wonderful, Steven. Not sure what it will take since nothing moves this stock, lol. But you never know. Painfully slow days, but very exciting.

[Pandora]

"My understanding is that the FDA wants to see the CR results of 20-25 patient at 360 days post initial treatment. " When this statement says "360 days post initial treatment" is it referring to 360 days beyond Patient One's treatment being the 'initial treatment' or 360 days beyond Patient Twenty-Five's treatment with the term "initial" being all

[TriumphSpitSix]

Another issue is the statement "treating twenty-five patients in early 2021" when it's already the end of Q2. "Early 2021" would definitely encompass Q1 and maybe the first month of Q2 but it definitely IS NOT "early 2021" anymore...