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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?


To: Bill Wexler who wrote (2061)1/27/1998 7:30:00 AM
From: F. Jay Abella, III  Read Replies (2) | Respond to of 7041
 
Bill:

<<<Wow. I'm impressed. Despite the fact that this is pure gobeldygook which completely evades the fact that phentolamine does not produce erections. Debating how fast it is delivered into the bloodstream is a red herring.>>>

Good point. When will someone tell us what ZONA found in their company-sponsored PK trials (and not what some researcher found in 1975 or 1981)? Did any of the ZONA phase III protocols have a PK component? If so, why was discussion of the following omitted from the white paper?

At what time points did phentolamine produce erections?
How much phentolamine did it take to produce this effect?
Were the results statistically significant versus placebo?
Was there any noted toxicity?
Did the drug or any of its metabolites accumulate in patients?
Were any of the metabolites found to produce adverse effects?
If so, is there a metabolite profile and whendid the AE's occur?

These are not difficult questions to answer if there is, as you say, a validated assay available with low limits of detection?

Doesn't it trouble you Keith that in the areas of absorption, distribution, metabolism and excretion, we have no answers from ZONA? If data are available from ZONA sponsored studies, could you please post it? If data are not available, do you know if SGP will be allowed to fill the PK section of the NDA with journal articles only?

Insights?

FJA



To: Bill Wexler who wrote (2061)1/27/1998 12:29:00 PM
From: Tunica Albuginea  Respond to of 7041
 
Congratulations on all the hard working detectives on this threa,Bill, Cosmos, Voodoo, Barbara ( please keep that Salvation Army link handy; perhaps post it periodically for ready reference in emergency situations such as a court order to lock up the palce ),even the hard working pediatritian Cacaito, for trying to save Investors' money . I am definitely reccommending that you all also volunteer your services to a certain Kenneth Starr across the Potomac
so that another similar charade will hopefully come to a speedy end and we can all go back to regular, more productive, endeavours.

As for me, I am still waiting for a reply from Dr Rubin as to how after " Due diligence " on Zona, he missed the pill for a spray.
litmus test is passed I WILL N O T < G G G > get into ANY " blood level " quasi-philosophical" " pseudoscience ", " blue smoke and mirrors " discussions on this thread. This is a warning < GG>.

TA

TA