What people are anxiously waiting for is whether THLD will apply for approval at FDA/EMA ( Europe ) based on the Phase II data they have so far against pancreatic cancer indication. However, they need to wait until they get the overall survival data to have a solid case.
Thld is in a lot of trials at different stages. The closest trials are the soft tissue sarcoma which is in Phase III and won't be completed for another year.
The trial that has everybody excited is the pancreatic cancer trial which is in phase II. The pancreatic cancer trial has released progression free, toxicity, and response numbers but not overall survival numbers. The O/S data won't be ready till the last half of this year. Patients in this study are still being treated and are alive and that is why the O/S numbers can't be calculated. The longer the wait on the O/S data the better.
If the O/S data comes back positive the company then will decide if they will continue into pahse III for pancreatic cancer or go straight to the FDA for approval with the data from the phase II trial. This will shorten the time to market considerably if it happens. If phase II data is good enough, and the FDA gives an accelerated review with approval, TH-302 for pancreatic cancer could be approved as early as the 2Q 2013.
There are no set dates for anything just best guess based on company information.
The promising thing about TH-302 is that it has been given to over 600 patients in various trials and at various stages of those trials and the result are consistent. Good response, with good efficacy and safety.
It is important to note TH-302 is usually a drug used in combination with other drugs for cancer treatments. It is an enhancer. As such the market potential is bigger, and more widespread.
This stock has already hit $9.00 per share and the company is still basically just starting into its first phase III trial (for STS). It is one of few companies that is making money without a product on the market (milestone payments will be considered as earned income)and has no debt. It also, has the financial ability to pay for more trials and in effect deepen their product line.
When TH-302 is approved you won't be able to buy this stock. The indications are it is a very beneficial and safe drug, as far as cancer drugs go.