That should reassure everybody ... and once again, our regular whiners lacked timing.
Theralase has confirmed a conference call with the Food and Drug Administration ("FDA") to discuss the design and endpoints of Study II, via a Pre-Investigational New Drug ("PIND") meeting in late June 2019. Pending completion of this conference call, the Company plans to submit an Investigational New Drug ("IND") application to the FDA and subject to their final review and approval, the Company will commence on-boarding institutional clinical oncology sites in the United States for Study II.
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Claridge - (5/30/2019 6:56:39 PM)
So far, there's no delays in the Ph. 2b
It's legitimate to ask some questions. But at one point, some should master a minimum of things! There are limits to post nonsense.
TLT came up with guidelines recently. They wouldn't have, if they were facing bumps or issues!
Some also have hard time understanding the recruitment, screening and enrollment processes and how unpredictable they are in terms of length/duration.
TLT/UHN have done everything to be ready for that, by networking community clinics, etc .... Remember also that direct sollicitation of patients BEFORE green light is given to the clinical trial (April 25 in our case) is clearly forbidden by regulatory bodies.
You've then seen clinical trials created in the Clinicaltrials.gov db (May 10) and then on UHN clinical trial site (May 24).
ClinicalTrials.gov record also mentions this, as posted earlier this week:
Screening Period
Patients will be qualified for Study entry by review of inclusion and exclusion criteria during the Screening Period, which will last up to 28 days.
So no need to go into all sorts of negative scenarios when we're still in the standard/acceptable timeframes. Anyways, we'll never be given all the insights, even if you're a shareholder, as Eoganacht accurately mentioned. That has nothing to do with TLT. All company keep things for themselves, when it's not material info.., competitive issues oblige.
Negativity on this board is probably what brings this stock price lower ... lolll Like shooting ourselves in our own foot.
We have especially couple of ignorant regular grumblers that are not even able to provide clear info. about what they bring forwards. And don't have problems with questions, but we know those that always doubt, that are never satisified, no matter what.
TLT management wants this much more than you and I. After all, that's their baby, they've put all those years of efforts and hard work into that company. They want this to advance much faster than you and I. Believe me.
If you have a problem of trusting Roger, Dr. Mandel, Dr. Lilge, UHN, PMH, etc ..., then just sell and go invest elsewhere that better suit your investor profile.
And despite superficial rants from our regular whiners, TLT has never been a one guy company as TLT has been working hand-in-hand with UHN. A one-guy company would have be impossbile with an elite partner like UHN. And impossible for such a complex and innovative R&D project. And impossible for an oncology related technology. Go listen to Dr. Lilge's latest presentations if you don't believe me. For those that took the time to watch them.