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Biotech Stock Mailbag: YM Bio, Hemispherx, Navidea

The other variable under consideration is trial endpoints. Jakafi was approved based on a primary endpoint that measured spleen reduction. That would be fine for CYT387 too, but it wouldn't capture data on anemia benefit/transfusion independence -- the drug's key differentiating characteristic. YM Bio must be thinking of way to design its phase III studies with either primary or secondary endpoints that will allow it to get anemia benefit data into CYT387's label, if approved.

YM Bio is two to three years beyond Incyte in the myelofibrosis treatment market. To catch up, YM BIO needs to be bold and produce data from phase III studies that will give doctors a compelling reason to prescribe CYT387 over Jakafi.

While we wait for YM Bio to announce phase III plans or a partnership (or both), the company will be presenting updated data from earlier studies of CYT387 at December's American Society of Hematology annual meeting. We last got meaningful clinical data on CYT387 at last year's ASH meeting.

YM Bio has traded sideways for the past year. Even with the new cash raised by YM Bio in 2012, the company's $277 million market value is still small compared to Incyte's $2.3 billion. That valuation gap should narrow, although I've been saying the same thing for more than a year and it hasn't happened.

I'd be happy to address any substantive argument for why FDA will approve Ampligen, the chronic fatigue syndrome drug from Hemispherx Biopharma (HEB - Get Report). So far, most of the responses to my column this week have been the "%^&* YOU, SHORT-SELLING SCUM!" variety. Funny but not very persuasive.

Biotech trader @sheffstation believes the changing environment at FDA -- regulators more sympathetic to patients groups, taking a more proactive, friendly manner with regards to drug approvals -- works in Hemispherx's favor.

Says Sheff: "A key point is that it took FDA only 13 days to accept the [Ampligen] NDA from their submission ... When does the FDA ever move this quickly? I take this as a very positive sign ..."

What Sheff forgets is that Hemispherx did not file a New Drug Application (NDA) for Ampligen this time around. The company filed a response to the FDA's complete response letter issued three years ago. Under FDA regulations, "an acknowledgement of receipt letter for the resubmission will be issued within 14 calendar days of receipt of the resubmission stating the classification of the resubmission and the performance goal date."
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