Hey Bill nice to see some thoughtful alternative opinion put forward for a change, but i tend to disagree with a lot of what you are saying here's why
>>The issue is that the FDA provides guidance guidance about whether they will accept your trial design and approval for things like Expanded Access. Remember the new charging rules that while not meant for profit do let co charge 70-80% of final costs. Recent hiv drugs have received this on non-sig phii data and atc should be easy...
>>Avexa could go for a special protocol assessment (SPA) SPA are not generally used in the well known hiv field, and are not likely here
>>We know that Avexa has been in contact with the FDA Avexa closed the Phiii with the fda support in their last contact, to consider a quicker path to market. The data has not be provided to the FDA to consider, and with ur orphan comments, is strange why u think further consultations with the fda would not help
>>an orphan indication for which ATC may be useful good point, and u go on to suggest that this may be salvage and result in a direct comparison with fuzeon. While orphan status will be nice and is achievable, there are other indications than salvage v fuzeon, which atc would win on safety anyway...
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