Jibacoa:
I am the least of investors on SI. And this is just my opinion. To me, BIOM (of which I own a little) is an honorable company with prospects, but it totally lacks present data to support a full commitment. In other words, for a phase III product, Theratope is still mostly about hope.
The Phase II study was designed to show that the best method of administering Theratope is after low dose iv cyclo. It did not prove that the Theratope vaccine causes a substantial survival benefit independent of all other variables. 50 patients received Theratope. 25 patients received iv cyclo, 13 patients received oral cyclo and 11 patients received no cyclo. All patients had a median survival of just over 19 months. A retrospective control group of matched patients predicted a 9.2 month survival period. The 25-patient arm that received Theratope and iv cyclo had a median survival of 26.5 months.
Soooo, (1) 25 patients, (2) "retrospective control group", (3) and cylo. Cyclo is chemotherapy! Although it was small ("not a therapeutic dose"), clinicians are increasingly showing interest in smaller, more frequent chemo doses for therapy.
It's my lame, lay opinion, but IMO there is just not enough data to bet real money on T. But hey, I'm the guy who believed maxim's management when they said liver mets was a previously defined and FDA approved subgroup that would, with significance, support approval. Frankly, I have held onto my BIOM for a long time hoping for BLP-25 to kick butt, yet the company has succeeded in confusing me about its results too.
As far as unblinding at the first look for efficacy. Jeesh, the hard endpoints of survival occur at 6/02 and 6/03. After coming this far, to unblind on 9/30 based on first look TTDP (with survival trends) would be a collossal error IMO, unless its p<.00000001, and the survival trend is actually significant and quite long. I don't hope for that from a carbohydrate vaccine at first look.
The best way to describe the Phase II is the way the company does: the results are consistent with a potential therapeutic effect of Theratope. Hey, it might work. I hope it does! If so, you could buy BIOM 30 points higher and still make a lot of money.
I felt the need to respond to your post on the valuation thread. I did not post this to pick a fight or to try to handle technical questions. The Yahoo board is the place for that. Just thought you deserved a response, and also might appreciate a second opinion, even one that barks and comes without a pedigree.
Good luck to both of us!
Wilder |
