Eoganacht wrote: It's easy to underestimate the difficulty of what Theralase is trying to accomplish. Theralase is trying to biring a new cancer drug to market, (in fact a whole anti-cancer technology targeting various forms of cancer - but one step at a time).
A study published in 2017 by the NIH asks the question,
"What is the estimated research and development spending for developing a cancer drug?" The answer was "
In this analysis of US Securities and Exchange Commission filings for 10 cancer drugs, the median cost of developing a single cancer drug was $648.0 million" https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710275/ This is
$829.30 million Canadian.
Great reasonong Eoganacht.
Theralase is trying to accomplish this at a small fraction of that cost with almost no product generated revenue while being beset by constant obstacles - poor performance by the laser division, laser recalls, the OSC lawsuit, ongoing delays, a lack of interest from prospective joint venture partners because the technology is not widely accepted.
Theralase is having to go it alone and has had to adopt a number of strategies to get to the all important goal of the first commercialization approval for
oncological pdt with TLD1433.
They chose
BCG unresponsive NMIBC as the first form of cancer to tackle because they knew a
phase 3 trial would not be required. Going into
phase 2 they did what they hoped would be one last large money raise to last until their first FDA approval. They have made serious cuts to staff, keeping only the absolutely essential staff needed to get to the finish line.
Now that success seems almost within reach they are setting their sights on the next indication. I think that talking about initiating both
GBM and
NSCLC trials was jumping the gun. Both
GBM and
NSCLC will require
phase 3 trials which will be expensive and take a long time to complete. IMHO, for the time being they should concentrate on one or the other, and the lmost reasonable choice to start with would be
NSCLC.
In 2020
25,000 American adults were diagnosed with brain or spinal cord tumours, while
236,000 were diagnosed with lung cancer. A successful lung cancer treatment should be far more profitable, and would impact the lives of far more people than a treatment for brain cancer. From a purely pragmatic point of view, it will be far better to have a
NSCLC trial going on with good preliminary results than a
GBM one when big pharma comes knocking.
In my opinion, when Theralase finally has the resources to do so they will also tackle
GBM and hopefully many other cancer indications. But, also in my opinion, it's pointless to look too far into the future until some hope of profitability has been established.