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


To: John McCarthy who wrote (839)10/15/1998 10:56:00 AM
From: StockDoc  Read Replies (2) | Respond to of 887
 
Good to see you here. This is my bi-monthly visit to the ol favorite to see how they're doing. Sad reminder of the poor design, using MTX as control. Nobody knows for sure whether MTX prolongs or shortens the life of patients, on average, with carcinomatous meningitis.

Now we'll see Depocyt for lymphomatous meningitis. At least they probably used a real control population (Cytosar?). That drug probably prolongs the life of some lymphoma patients (approved). Let's see whether they provided scientific evidence that Depocyt helps these patients.

I expect the FDA to keep its standards, however. The former case was less than perfect, and the FDA recognized this with a non-approvable letter. If the number of evaluable cases is low, the identity or difference tests are not OK, the prospective criteria are not met, I have hard time top believe that the FDA would create a precedent of approving the drug.