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

To: Dr. John M. de Castro who wrote (744)	3/5/1998 1:52:00 PM
From: James Silverman	Read Replies (1) \| Respond to of 887

Hey John, Others, A few points. 1. Less frequent administration is not exactly apples to apples, since MTX is given via injection and DC is given via intrathecal injection (spinal tap). Spinal taps aren't exactly a pleasant experience. 2. They presented data for only 20 patients for DC. 3. Under their original FDA coordinated plan, Depocyt for NM was to be more of a secondary indication. With Leukemia/lymphoma originally planned to be the initial indications. So its a bit of a stretch to say the FDA led them astray, or that ODAC ignored the FDA directive. Yes, they ran the NM along the FDA guidelines, but they were also supposed to have completed their other trials beforehand which would have given the panel much more food to work with. Which goes along with a question Baird Soule (?) asked a few months back in regards to pushing secondary indications first to get on the market. It may not be as easy as such. I attended ODAC and it wasn't pretty. The panel was comprised of a nice cross section of oncologists/scientists/practicing physicians. The consensus among them was that this would likely be a third line treatment for NM and they very much would like to see the results of the other trials Depo is running, when they are completed, which would allow for them to make a more informed judgment. Which begs the question as to why the other trials are taking so long, and why they disregarded the original trial plan order.