RE:RE:RE:swing back between hope and frustration From an idea 13y ago to mid-Ph. 2 pivotal data that is superior on 6 key aspects to anything on the market, including the most recent competition, but apart from the market valuation, TLT management delivered on all fronts as we are awaiting the FDA decision for Breakthrough Therapy. We even capture the interest of Canada's highest lab in Winnipeg with an unexpected indication (COVID-19).
TLT management having large sum of money at stake in this play, and this long journey having been their project over the last 13y, doubting about their seriousness regarding what they've done with the BREAKTHROUGH application of this process is a bit amateur, especially when we know they teamed up with a Harvard biostatistician to ensure data is as the FDA wants it and that nothing is left to hazard This major Breakthrough milestone represents much more than just money for them, when compared to us. And it has always been a do or die for any biotech and TLT is no different.
In 2014, long before the Ph. 1b, TLT management made it clear and official that they would go all alone until the pivotal Ph. 2 in order to maximize shareholders value when negociations would come. That obviously implied a low valuation until then.
The whining of some is not new, looks "Executive" on the surface and has been recurrent over the years. It changes nothing. TLT executed on its initial (2015) plan, on a shoestring budget, with lots of obstacles and challenges and looks like they've been right as we have something that aims at a next SOC.
Financing in today's world is extremely challenging, to say the least. TLT also indicated at the last AGM that they will proceed with small pps until a jv discussion with a big pharma concretize or that financing conditions improve (with the grating of a FDA Breakthrough designation for example). So that should be no surprize to anybody by we still hear some "unsatisfied" or "surprized" posters! Some are never satisfied either.
Granted FDA Breakthrough designation will help open the doors as it comes from THE regulatory body that identifies the future SOC.
Whiners can whine all they want, it is TLT management that brought us to the door of a binary FDA Breakthrough decision. It's TLT innovation and execution that allowed us to be in this stock at this amazingly low price. Any privately owned biotechs are being IPOed at a minimum of 10$US+. Our down side is 0.23$CAN. Our upside is 5-10-20$CAN+ depending on how things play out. Still, we have grumblers! And again, just ahead new MD&A data!!! Isn't strange, one more time?!
Our faith is no more in TLT management's hands since a long time but rather holds:
- on a binary FDA Breakthrough decision,
- one big pharma's willingness to see PDT/PDC's as its next oncology platform and finally,
- a final commercialization decision by the FDA
TLT has done what it had to do, that is to deliver pivotal Ph. 2 data ´, reach 50% of enrollment and activated the FDA Breakthrough designation application process and the discussion process with big pharmas.