Replies to post #120093 on Biotech Values

[mouton29]

And yet, how many times do we see a randomized trial fail because patients on the control arm did better than expected? Whether that is because the care in clinical trials is better than that generally available, or because the patients in the trial have different characteristics than those for which your "pretty much know results" obtains, or for some other reason, I don't know.

I admit, all of this is theory, certainly if I or a family member needed to go onto a trial, I would not be happy about the chance of getting a placebo. I'm sure as you know, in some trials --e.g., Dendreon -- the trial allows cross-over to the treatment arm after progression, some consolation. But that makes it harder to prove the treatment works, since it is, to some extent, competing against itself.

This is all theory since the FDA requires at least one randomized phase III trial, so its not as if companies have a choice.

I think this all started with the observation that the results so far were not based on a randomized trial, and so were less reliable. I am pretty sure David Miller would agree with the first part of your last sentence, that there should be randomized trials early on.

[DFRAI]

OT - ONCY trade

we had a symmetrical triangle breakout, price to 8.50-9, i would say its a pretty good trade and place a mental stop at 5.80

[DewDiligence]

Here’s another oncolytic virus:

http://finance.yahoo.com/news/Jennerex-and-Partners-Present-prnews-516659871.html?x=0&.v=1

Jennerex is a private company but its EU partner, Transgene, is traded in Europe.

[microcapfun]

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