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 : LIPO-Liposome -- Ignore unavailable to you. Want to Upgrade?

To: dalroi who wrote (766)	8/24/1999 4:56:00 PM
From: KM	Respond to of 900

I found this on the Yahoo board: The key study is the combo treatment with CPA (297 patients). Both had an equal response rate (41%) The Risk Ratio for Progression Free Survival(Evacet:doxorubicin)(1.038)and Risk Ratio for Progression Free Survival (0.979)are much more in line with equal efficacy and don't really trend one way or the other. However, only 5 of 148 developed heart failure in the doxo group (3%)versus (0%) with Evacet. This is the indication for which they are seeking approval. The final Phase III study versus epirubicin with CPA is a no-brainer with Evacet showing a strong trend toward being more efficacious with no heart failure in either group. I think this is why the European filing is for Evacet alone and in combination with CPA. Finally, let me say that I like this drug and am very long Lipo. If the ODAC is willing to accept a single relatively large Phase III study for the approved indication and to consider a MUGA scan as being a marker for future clinically important disease, then this drug will sail through. If they only consider overt heart failure important it will be closer in terms of the vote but should still pass. Heart failure is a serious disorder but a skeptic could conceivably ask for more data to prove that efficacy is equivalent (i.e. a second Phase III study Evacet + CPA versus doxo + CPA. My take - 85% chance of vote to recommend approval, 15% chance request more data. I personally would vote for approval based upon the info I have and would also prescribe this drug over Doxo for metastatic breast cancer. Approval now instead of in 2 years would save a significant number of women from heart disease. I also think the wide acceptance and growing realization that Abelcet is superior to ampho will facilitate approval of Evacet. The concept of lipid-based therapy has been proved;this will provide a very important mind set for the advisory committee.

To: dalroi who wrote (766)	8/24/1999 9:24:00 PM
From: KM	Read Replies (2) \| Respond to of 900

Okay, someone educate me. I just read the transcript of the earnings conference call in July and quote the following passage: *********************************************** "As far as the timing is concerned, we have just learned that EVACET will go before the Oncology Drug Advisory Committee here in the U.S. on the afternoon of September 16th. We expect to get an answer from the FDA sometime after that meeting, but before the end of the year." ********************************************* Now, if I read this correctly, it sounds like they go in and make a presentation, answer questions, or whatever, and then, the FDA goes away for awhile and issues a recommendation at some later date (not the same day). Is this correct? If so, why is everyone keying on that September 16 date if there will be no response that day? This is rhetorical question. I have no prior experience in this FDA procedure so I'd appreciate any insights. Thanks.