Competition? Maybe someday, but not soon.Some of my fellow investors are a little jumpy. (They probably don't belong in biotech stocks.) There are 10 competitors listed on page 18 of the TST corporate presentation. Heat Biologics is listed as competitor #8. No competitor is as far advanced as TST. Many, possibly most competitors' trials will fail. On page 7, it says the FDA has not approved any new bladder cancer treatments since 1998. That is a 17 year drought. So just because TST is going for approval with the FDA in 2015, suddenly other competitors are going to succeed, wrecking the market? Yeah, right.
Heat Biologics in in Phase II. TST was in stage II prior to when I invested in TST. I started investing in TST 7 years ago. Phase II is where you are trying different combinations of therapy in small quantities of patients to see which approach works best. The description of Heat Biologics clinical trial design means there will be about 25 people each category. Then they have to run a phase 3 trial which focuses on the treatment approach that phase 2 shows is most promising. 25 patient trials are too small to go straight to FDA approval. Here's the article that I pulled from the previous post on this board:
"Heat Biologics' Phase II, randomized, placebo-controlled and double-blind incorporates roughly 100 patients and comprise several arms: low dose HS-410 with BCG; high dose HS-410 with BCG, placebo plus BCG, and HS-410 as a monotherapy. The last arm is vitally important to show HS-410 as a monotherapy for bladder cancer and may, if successful, direct the design of a pivotal trial to possibly introduce to the medical community HS-410 as a replacement for BCG - a revolutionary step toward treatment of this expensive and prevalent disease. Patient enrollment is expected to complete by 3Q2015"
There is also an ethical issue associated with the above trial. It seems to me that the patients all have to be BCG refractory or recurring. If they are BCG-treatment-naive (never treated before), then you would be asking patients to gamble their lives on an unproven treatment if you put them in the "blind no-BCG" cohort. Their doctor might to go for it. So I don't think Heat Biologics is going to replace BCG as the first-line treatment.