ONCY
>>standard of care for specific type of cancers is pretty much a known result - easily quantifiable based on the last 1-20 yrs research which has not changed much.
example - pancreatic cancer patient - on standard soc lives 6 months
what is the value of subjecting those patients to another round of SOC when you know the outcome - 6 months
hence my reservation about randomized trials.<< (DFRAI)
I do not mean this to sound like a personal attack, but it is rather amazing that you make just about every biotech newbie mistake in the book. (These are all from your posts on ONCY - with only a small amount of exaggeration.)
1. Randomized trials are not necessary because we can just compare to historical data - which doesn't change much over the years.
2. Success in animals implies success in humans. [Virtually no drug makes it to Phase I w/o success in animals!]
3. Success of a somewhat related drug implies success of my company's drug. [But OncoVex, a Herpes simplex type 1 virus *engineered* to not replicate in normal cells and *engineered* to express GM-CSF, is EXTREMELY different than the naturally occuring reovirus!]
4. If a fund buys a lot of my company, they must know what they are doing; that is evidence my company will succeed. [If you think a fund does better DD than you ... BUY THE FUND!]
5. There is no need for a pivotal Phase 3 trial to be built upon a similar randomized Phase 2.
6. If the CEO says it - it's true.
7. My company would not have moved into Phase 3 and started preparing for launch if they were not fairly sure of success - and since they're fairly sure, I can be as well.
8. If my company pays a well-known company to manufacture the drug, it is a very good sign. A well-known company wouldn't waste its time with losers. [The key word here is "pays".]
9. If my drug + a standard drug improves the condition of cancer patients, then it is clear that my drug works.
10. There is nothing suspicious about my company carrying out a string of small, single-arm studies over ~ a decade that prove nothing regarding efficacy.
11. If the stock goes up, that's a good sign. If it shows weakness, it should probably be sold. [See post #120060!]
I'm sure I missed a few.
All I can say is ... good luck!
micro
Life is an IQ test.
email: microcapfun@yahoo.com