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Biotech / Medical : T/FIF, a New Plateau -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (1240)	7/3/2002 6:13:59 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 2243

related..... It appears that NBIX, among many, has grasped the raised bar. Is that a function of timing, serendipity that SEPR got the short end of? Or did SEPR run through some FDA stop signs? Good regulatory groups make a difference. Gary Lyons doesn't say much, but if you ask him a question, he tries to give you a good answer. Maybe that's a spirit that extends throughout the organization? If a company doesn't cut corners, constructive FDA guidance can assure that trials are sound clinical experiments, with a set bar, rather than fodder for arguments/blame.

To: Biomaven who wrote (1240)	7/4/2002 7:19:42 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 2243

Peter, I think that it is common practice in drug development process one can not start large pivotal trials without long term animal toxicology study or good PK/PD studies. If safety issues emerge after pivotal trial is completed one need scientific explanation, sometimes going back to animal studies, or PK/PD study, or drug-drug interactions, or… is necessity. I believe that we do have constant dialog between FDA and drug developers. Quality of this dialog is what makes difference at end. In ALKS (J&J) and SEPR case I do not have true picture whom to blame for failure, or “Not Approvable”. Maybe true story will come out? Do you think that FDA will ask for additional animal data (or any other data) if there is no connection with human results? FDA does not dictate every issue in drug development process. They do help with recommendations and suggestions. They are not perfect, far from that. Why companies have outside consultants, regulatory department, and all other technical support? SCIO’s Natrecor story is typical one. Sloppy clinical results and you are going back. Do it right and we are with you. Do they balance candidate safety with medical needs? In majority of cases safety issue bar is for those who will abuse drug, not for those who are in real medical needs. Unfortunately second ones suffer because of the first. Miljenko

To: Biomaven who wrote (1240)	7/5/2002 12:27:04 PM
From: Czechsinthemail	Read Replies (2) \| Respond to of 2243

It has been interesting to read discussions of the FDA and possible changes in their selection/rejection criteria. It is a bit reminiscent of Kremlinologists back in the 20th century, who made a career out of inferring the inner workings of the Soviet government from limited visible data. I would agree that the FDA should be upfront and forthright in communicating what their standards are, though I suspect FDA people might argue they have been doing that all along: new drugs must be safe and show efficacy. My beef is not so much that they have tough criteria or even that they raise the bar, but rather that it seems hypocritical to raise the bar and then not review drugs that made it over an earlier low bar. If the real issue is patient safety, drugs that can't demonstrate it shouldn't be on the market. Here the political predicament of the FDA may come into play. The cardinal sin is not having failed but "appearing" to have failed in their regulatory function. I think this is the main reason for stealth shifts in policy without retroactive reviews of previously approved drugs that would likely not pass muster using more rigorous criteria. I would also agree that finding the balance that best serves patient needs is important and at times difficult. You mentioned long-acting Risperdal. One has to wonder how big the picture those reviewing it are looking at in making their determination. Is it simply a specific thumbs up/down on this particular application or is there also consideration given to other drugs waiting in the wings (e.g. NVS/TTP's iloperidone) that might offer better solutions? I'm not sure what the reasons were for declining the JNJ/ALKS application, but after receiving a baptism by bath in DepoTech many moons ago, I learned not to assume that long-acting formulations of already approved drugs would be a slam dunk.