Hemispherx BioPharma (HEB)

[ERoche]

Typically, at least from my limited experience they often dont vary from their course and by nature of there attack and the time granted by Finra they can keep it slowly rolling down hill.

I think most assumed HEB was a done deal and would never really be able to make another go at it given the cost of the FDAs request of another trial.

The new legislation and the FDA's revised mission openened the door to skirt that expense with an outright approval and or at least be able to bear it with an accelerated approval that allows the marketing and sale of Ampligen in conjunction with a new study.

Given the good safety profile etc and the fact it seemed the CRL came largely due to inconclusive proof of a clinical benefit (mostly due to the nature of the indication itself) to the degree needed to make the cut that the new guidelines FDASIA put in play dramatically increase the odds that this sees at least Accelrated approval.

That creates a huge problem for you know who as this has been played on their end like a write-off and with the mindset that funding that would be needed to meet the FDAs CRL requirments would have meant massive dillution and futhered there agenda.

They are screwed if it gains outright and or accelerated approval
the question is do they keep the poker face up too and thru adcom and PDUFA and or to they take care of there issue on the froint end. They are likely weighing their options