ADCOM Agenda Released Today
$Spectrum Pharmaceuticals (SPPI.US)$ Some folks may be asking what happened to the stock today? Well, today was the day that we learned what the ADCOM would be reviewing in this week's meeting with Spectrum.
In the documentation you see concerns about side effects, efficacy, and dosage. These are the things that Spectrum will have to defend against and prove to ADCOM that their concerns are unfounded.
These concerns led to the drop in stock price today. Whether or not the concerns are valid, remains to be seen. In reviewing the documents, it is plain to see that there is confusion on the FDAs viewpoints as they compare to drugs that are related to other indications, their ORR number comparisons appear to be incorrect, and their concerns on side effects do not appear to be taking into consideration that ALL therapies for this indication has major side effects.
If you take a moment to read the comments made to the panel by outside entities and patients who went thru the trial, you will see people who all think this drug is a must have and that the side effects are manageable. It would be irresponsible of the FDA not to approve, but with the FDA, you never know what you are gonna get....
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仁者无敌的乔休尔 : That is correctly