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Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?

To: ForYourEyesOnly who wrote (614)	12/19/1997 7:56:00 PM
From: Cymeed	Respond to of 887

Hello, THC, while I am not a medical person, I will try to answer some of your questions based on the understanding on my part: 1. Depocyt is not dead yet. They can ask FDA for a "Provisional Approval". That is, approval for marketing without the backing of a committee. Company said there is a marketing problem this way. But if it's me, I will start this DepoCyt "provisional approval" right away. It's always nice to have some products and let the doctors and patients be the judge. However, there is always a possibility that FDA will not give them this approval. Company said during the conference call that they will sit down and talk with FDA as early as January in defining a path forward. Depo can also collect more data, filing a new application, start a new meeting, etc. But time is the problem. I figured if they choose this path, it will be end of 1999 for next ODAC meeting. Do they have such a financial strength to sustain such a long struggle ? Depo can also pursue Canada approval (application already in) and Europe approval (not decided yet whether to submit application). 2. One question being asked during the CC today was DepoFoam's toxicity, which of course is the key question of whether DepoFoam delivery technology is still viable. The company said DepoFoam is not toxic, thus why they will use it to carry drugs such as epidural (for very fragile and health patients). But question to the medical experts of this thread is, will DepoFoam enhance the side effects of certain drugs ? I had hard time to understand their discussion today in FDA's impression of higher toxicity than control, why ? 3. Depo Mophine is only at P2 trial. Its efficay and side effects are not known yet. How can we now what to expect ? Personally, I am more concerned about the viability of its core technology and the financial health of this tiny company, given it will most possibly be sued by shareholders and its partners might pull off contracts, etc. The idea of DepoFoam still sounds good. But can they prevail after such a astounding failure ?