These are not similar technologies. Perhaps it is different rules for topical applications than for oral, IV or subcutaneous, and perhaps the rules are different for different diseases. However I don't agree with a blanket claim that biologics don't need phase 1/2/3 trials. For example, I know that Pfizer, E. Lilly, AZ etc etc are all spending multi-millions doing phase trials on biologics for rheumatoid arthritis.
If someone who understand the FDA guidelines can clarify this I would be grateful.
I used to have a holding in TIS, that's why I keep an eye on it. I really like the product/technology but earlier this year lost confidence with management over-promising, so I have put my limited resources elsewhere - for now anyway.
TIS Price at posting:
57.0¢ Sentiment: None Disclosure: Not Held
