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Biotech / Medical : IMNR - Immune Response -- Ignore unavailable to you. Want to Upgrade?

To: AHM who wrote (900)	7/10/1998 12:10:00 PM
From: jake burns	Respond to of 1510

Also, in the article was a quote by Peter Johnson that AGPH will unveil later this month an "innovative plan to aggressively pursue development of the newly licensed drugs." What this means with respect to IMNR's remune is unclear, obviously. one doesn't know if that statement includes all of the 3 drugs agph licensed. Good luck.

To: AHM who wrote (900)	7/24/1998 7:29:00 PM
From: AHM	Respond to of 1510

Extremely informative posting from Yahoo: QUOTE: Being in the Army I learned early believe nothing of what you hear and only half of what you see, so after Deb Altman told me that the FDA frowns on the company providing link sites to the material presented at the conference so I decided to check. She was right and here is the FDA's reply: Mr. Becker, Without knowing the exact nature of the material, it is difficult to say why the company chose to respond to you in that way. However, I can outline the issues of the law and of FDA's concerns in general. While a drug is still under study, there may be many preliminary indications of safety or effectiveness that change as more is learned about the drug. What may be a reasonable statement at one point in the testing may be misleading later. In addition, impressions that are conveyed about a drug during the testing phase may carry over to the post-approval stage, but it may no longer be true, thus misleading physicians. For these reasons, the law forbids drug companies from promoting products before they are approved by FDA. However, FDA recognizes the need for free scientific exchange about experimental drugs and even the requirement that the Securities and Exchange Commission imposes on publicly held companies to keep their investors informed about the progress of products in the pipeline. That puts the companies in the position of walking a tightrope between what is legitimate information exchange and what is unlawful, pre-approval promotion. In general, companies leave the scientific exchanges about the drug to their principal investigators, who are usually experts in medical colleges. The statements companies make in filings with the SEC are usually carefully worded so as not to overstate the potential value of the drug. The problem with a company posting on the Net statements or papers by its investigators is that legally it then becomes a statement made by the company. If it contains statements that would be regarded as promotional of the drug, as may be the case with investigators who get enthusiastic about the drug they are studying, then the company could be cited by FDA as promoting the drug before it is approved. I hope this explains why the company may have been reluctant to post the proceedings of the conference. You may be able to get such proceedings or papers from other sources on the Web or from the medical literature. Jim Morrison CDER Ombudsman END QUOTE