Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biota -- Ignore unavailable to you. Want to Upgrade?

To: Angelo Ferraro who wrote (36)	4/11/1999 4:30:00 AM
From: Henrik	Respond to of 46

BIOTA HOLDINGS LIMITED 1999-04-08 HOMEX - Melbourne Biota Holdings Limited advises that its development partner, Glaxo Wellcome plc, has been notified by the US Food and Drug Administration (FDA) of their intention to continue the regulatory review of the application of the company's influenza product, Relenza (zanamivir), beyond the April 27th action date. Under US law, companies pay a user-fee to the FDA with each drug application. In return, the FDA aims to complete the review of the application, by a specified date, which in this case was April 27th. This extension will allow the company and the FDA more time to continue their review of the data on Relenza and follows discussions between Glaxo Wellcome and the FDA after the February 24th meeting of the agency's Antiviral Drug Advisory Committee, which did not recommend approval. Glaxo Wellcome has already received approval for Relenza in Australia and Sweden. Sweden is acting as the Reference Member State in the Mutual Recognition Process for the purpose of obtaining approval in the other countries of the European Union. Relenza is the first of a new generation of drugs known as neuraminidase inhibitors. Its mode of action is to prevent the spread of infection from one cell to another within the respiratory tract. Relenza is delivered via an inhaler, direct to the airways where the virus replicates. Glaxco Wellcome is a research-based pharmaceutical company whose people are committed to fighting disease by bringing innovative medicines and services to patients throughout the world and to the healthcare providers who serve them. Biota is an Australian listed company (BTA) based in Melbourne and engaged in the funding and management of a research and development program focusing principally on the discovery of new human pharmaceuticals for the treatment of cancer and viral respiratory disease. The company's ADRs trade in the US (BTA-HY) on the pink sheets at a ratio of three shares to each ADR. For further information, please contact: Richard Wadley Elizabeth Field/Michael Moore Chief Financial Officer Turnbull Porter Novelli Biota Holdings Limited Telephone: 61 3 9289 9555 Telephone: 61 3 9529 2311 Biota's announcements may be found on their website at www.biota.com.au

To: Angelo Ferraro who wrote (36)	4/11/1999 6:30:00 PM
From: A.J. Mullen	Respond to of 46

Angelo, Thanks for that article. It was very informative, and I thought quite fair. It seems as if the improvement brought about by the drug is not large, too small to be distinguishable when taken with the palliatives. if it were available now, I would probably try it, preferring something that acts on the cause to taking palliatives taht have their own problems. The trouble for Glaxo is that if they take that tack, then they presumably will have to run a completely different trial with volunteers agreeing not to take any other cold-medications.