Theralase Technologies Inc. V.TLT

Accelerated Approval and Priority Review.

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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 of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with the TLC-3200 medical laser system ("TLC-3200"), to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with BCG-Unresponsive NMIBC CIS, with or without papillary Ta or T1 tumours. FTD can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.

https://theralase.com/theralase-granted-fda-fast-track-designation-for-nmibc-phase-ii-clinical-study/
November 23, 2020


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12 patients reported treated on September 24, 2020.

[skier59]

The really good thing about this Fast-Track Approval, is that now I'm confident we have enough cash to see this through to commercialization. Would certainly like to see a report on how many have been treated since the study was opened up again, but we might have to wait for the Q4 Progress Report, which would come early January. If we can hold a base around this level I doubt we will see many

[tamarindo1]

[Pandora]

Same subject different object. Vaccines - supposedly the U.S. airlines are starting to distribute vaccine around the country and implementation should start the week after. The U.S. has done considerable studies to identify the most vulnerable with underlying conditions - and these are primarily seniors. In the meantime I believe I heard a statement from Mr. Trudeau that he felt a majority of

[Pandora]

So does covid eliminate the common flu? They are both corona viruses. https://calgaryherald.com/news/local-news/with-december-around-the-corner-no-flu-cases-yet-detected-in-alberta?utm_term=Autofeed&utm_medium=Social&utm_source=Twitter#Echobox=1606438837

[BlueMetal75]

Covid is caused by coronaviruses; the flu is caused by influenza viruses.

[Pandora]

Just to expound a bit more: Influenza (the flu) and COVID-19, the illness caused by the pandemic coronavirus, are both contagious respiratory illnesses, meaning they affect your lungs and breathing, and can be spread to others. Although the symptoms of COVID-19 and the flu can look similar, the two illnesses are caused by different viruses. COVID-19: Caused by the 2019 coronavirus, also known

[Rumpl3StiltSkin]

The Common Cold is a corona virus Pando. Isn't that what you meant?

[Pandora]

I could say that or I could say that I just meant to say viruses but I have corona on my mind and I got carried away with my typing -- fingers working, brain not! Nothing serious, I'll do the easy out i.e. age related :-)) Forgot we always have fact checkers.

[Rumpl3StiltSkin]

Well, maybe, once we have Covid 19 vaccines out there, we will also have good therapeutics that will finally be a 'cure' for the proverbial 'common cold'. :-)

[Pandora]

Rumpl3StiltSkin, being an old guy I would feel a hell of a lot more comfortable if we had the medicines/therapeutics to actually make a person better after catching the disease. The vaccine is good and after a lengthy rollout and the "time" factor we will know how effective it is. In the meantime people just keep catching the disease and many, many end up in hospital and there is no real

[Rumpl3StiltSkin]

I hear ya Pando, I don't think the media/govts have been straight with us. I mean they never gave HCQ any love once Trump mentioned it, yet the countries where it is widely available or taken regularly for Melaria, etc., there have been much less death/hospitilizations. So get a hold of some Q at the very least, Yes, large amounts of D3 helps, and Pepcid of all things, one or two a day

[gojotv!]

Posts like this are why I get my medical advice from reliable, vetted sources, not from random stock traders posting on a bullboard... Sheesh! The internet makes some people crazy.

[Pandora]

 A couple of good quotes I ran across: "Getting offended by something written on the internet is like stepping in a pile of dogshlt instead of walking around it." also "I did not survive drinking Everclear (grain alcohol) as a kid to then be taken out by a virus named after a beer."

[skyhawk1]

Yeah it's pretty easy to step in it on this board bcuz it's EVERYWHERE!! The smell of the ski 'DOGSH!T' loser & all his conjob aliases is overwhelming on here?! it's best to IGNORE the smell & do what I do, get on with life & just visit the board once in a while for TLT news & updates that r important to our investment!!   P.E.R.I.O.D. .

[Rumpl3StiltSkin]

The data is out there Gojo, you could have a look yourself, or hey just be a lazy-bones and let CNN give you all the details.

[gojotv!]

Oh, really, Rumple...? You read the Lancet? The New England Journal of medicine? The Mayo Clinic website...? Or do you gobble up the snake-oil sold to you courtesy of YouTube and "naturalnewsdotcom"? i stand by what I said because your very post confirms it. You are among the growing masses whose appetite for sensationalized disinformation have them seeking vetted, science-backed info

[Rumpl3StiltSkin]

Gojo, I don't see any data here in your response that would move me off my position. Which is based on graphs I've seen comparing countries that blocked HCQ in some way vs those that didn't. Those that didn't did FAR better in both Hospitalization and Mortality rates. Trump was right to back HCQ from the jump, the USA would probably be doing much better IF we'd have followed

[fasttrack5]

WHO announced that the hydroxychloroquine (HCQ) arm of the Solidarity Trial to find an effective COVID-19 treatment was being stopped.  The trial's Executive Group and principal investigators made the decision based on evidence from the Solidarity trial, UK's Recovery trial and a Cochrane review of other evidence on hydroxychloroquine. Data from Solidarity (including the French

[Pandora]

And who would have any reason to doubt W.H.O.? :-)) https://techstartups.com/2020/08/05/countries-using-hydroxychloroquine-far-fewer-covid-19-deaths-countries-dont-studies-association-american-physicians-surgeons-shows/ And I'm sure many will slam this data. Question is, who (and that's not specifically in reference to W.H.O.) is really telling the truth, and where do you want to put

[tdon1229]

The WHO trial and decision to stop the trial was based on treating already-hospitalized patients.  HCQ's efficacy is best when used as a prophylactic or during the first five days following exposure during incubation and prior to hospitalization, and also with zinc which prevents the rapid multiplication of the virus in the patient's cells, as well as with a suitable antibiotic to

[Pandora]

 "Politics and media have distorted the arguments to suit their own desires." You can say that again -- over and over! Even when changing the subject.

[Rumpl3StiltSkin]

The point of HCQ as a treatment, from docs that have actually been using it in the field, is it has no affect if used late in disease progression. If you get to the hospital with mild symptoms then I think yes, maybe use it along with other treatments like Zinc, definetly use it early and as a preventative. Many of the HCQ studies, especially once it was politicisized, were designed as late stage

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