Something I don't understand, and would welcome any input.
When the FDA released the final questions to ODAC a day or so before the meeting, I didn't understand the ramifications of the last paragraph, which started "Question to ODAC (VOTE):" and went on to ask the question about the need for an FDA validated diagnostic test.
I didn't realise it meant that was the only thing the committee would vote on today. It seems we didn't really have any hope of getting a recommendation today.
What was the point of assembling the experts, and having the company give a full presentation, if they weren't going to vote on matters of efficacy and safety?
I would have thought it in the FDA's interests to have the committee assess the material in front of them today, and either say no, or give an approval subject to the diagnostic issue being sorted out. Do they now have to re-assemble the experts and go through the whole thing again? Will we get the same panel on the committee next time, or different committee members? What would be the point of having the company do weeks/months of work on the diagnostic test, only for the FDA to knock back the drug anyway?
I think we would have seen a different market reaction today if the decision had been 'Recommended for approval, subject to...'
Regards.
CXS Price at posting:
44.0¢ Sentiment: Buy Disclosure: Held
