RE:RE:RE:List goes on and onOh dear, oh dear.
Based on the fact that an anonymous poster claims he talked to someone who talked to someone that the FDA is asking to see 18 month data on the 14 CR patients Benedictus concludes:
" If Theralase is aiming to supplant the currently approved SoC, shouldn't the same safety and clinical measurements for those drugs apply to ruvidar? It's difficult not to see this as an arbitrary moving of the goal posts." Of course it is difficult not to see this as an arbitrary moving of the goal posts if this claim is true - but how do we know it is true when we only know about it as an anonymous third hand report? And even if the FDA wanted to see that data we don't know if BTD is in any way dependent on it.
This is not the first time the anonymous person who posted this rumour has talked about the 18 month request from the FDA. But previously it was just a speculation based on his experience with clinical trials. It has now been transformed into 3rd hand witness testimony.
I agree that clear thinking is impeded by unacknowledged agendas, the ignoring of nuance, and by confirmation bias.
But if you want to understand the big picture you need to clearly distinguish between fact, speculation and rumour.
Benedictus wrote: DJDawg wrote: People are calling each other pumpers and bashers....can't we just strike middle ground here everyone?
This company has major problems in the past. I don't have faith that they are the best team to get the job done but they are the one we have. I'm here because the science, which originates with Dr. MacFarland and the trials, which are supervised by non-TLT, indpendent investigators, are very very promising.
Regarding the numbered points, there is lots of validity to some of them.
1. OSC settlement: RDW amateur hour example where he was too too optimistic about sales and aprovals. However, his settlement was milder because they noted that he never sold any shares. He wasn't pumping and running so much as bad judgement and enthusiasm.
2, 3, 4, 5, 6, 7, 8. Those of us who have read the reviews of people who have worked there, RDW is a control freak and was never letting anyone do anything with company even if he wasn't CEO for 5 year. I'd like to believe the turnover is because he is a bad boss, which is a problem, but a common type in the corporate world.
9 They totally miss deadlines that they created. Also amateur hour stuff.
10. Difficulty raising funds: so many reasons for this I guess. Being Canadian, on TSX venture, having the CEO's bad rep with OSC etc. Further evidence of poor leadership.
11. This one is tricky. Hard to know the science and whose fault it was. I don't hold this against TLT because this is so new, mistakes can happen.
12. From talking to someone else who chatted with RDW, the FDA wants 18m confirmation that the fourteen CR patients are still CR and want a central pathologist to confirm no cancer on the samples for those same 14. That explains the BTD evolution. Still slow and disappointing.
13. Agreed. Way way slow on the GBM work.
14. Viral is done. This is never going to be a money earning thing people. It may evolve but not in some cash cow way.
15. agree. updates nice but they have no money so no one is surprised that new work on next generation agents hasn't happened.
RDW and team had the smarts to evolve this in the first place. Not many physiotherapy laser companies are led by people that think about oncology. Not many oncology companies have any interest or knowledge about lasers. So TLT will forever be the respected by me for this. Plus they found an applicable cancer that doesn't need a phase 3 trial and is common enough to earn money in the medium term. They did well by that.
RDW and team don't have the leadership style or management skill to do any of this well. But like I said, they are the team that we have. I don't think there is anything malicious or corrupt about anything they have done. Just bland dysfunction.
As it is we have 1.5 m more in cash and will almost certainly get BTD. Things will progress. There is no pile of 0.22 shares about to be dumped on the open market so the price will drift up.
As a personal comment, there is a teenager on my street who is slowly dying of a cancer growing out of their face. It is tragic to see. I looked it up and it is rare but incredibly avid to iron. Which means it will take up TLD-1433 well. It is superficial so xray activation will work well. None of the umpteen cancer therapies she has tried is working. That is the true big picture for me for TLT. Using cancers' love of iron to take up the TLD-1433 and trojan horse the sh#t out of it. Will take time to get there but that potential is way more exciting than anything we have heard so far.
So ya, can we find some happy medium between bashing and fawning? That would be nice.
(sorry about the essay)
Extremely well said Dawg. I would add that boards easily devolve into polar echo chambers where realists are labeled bashers/soft bashers with agendas and all nuance or willingness to try and understand the entire picture is readily dismissed for the comfort of group think and confirmation bias.
From your item 12 above do you have any insight as to why the FDA would apply a higher 18 month bar to this treatment? If Theralase is aiming to supplant the currently approved SoC, shouldn't the same safety and clinical measurements for those drugs apply to ruvidar? It's difficult not to see this as an arbitrary moving of the goal posts.