Traders Eye Chelsea Therapeutics (CHTP) Ahead of Northera PDUFA Date
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Biotech traders were toying with Chelsea Therapeutics (Nasdaq: CHTP) today ahead of tomorrow's PDUFA date for Northera.
In February, and FDA AdCom voted 7-4 in favor of Northera approval.
Recently analysts at Needham & Company commented on the upcoming decision.
"In our opinion, the favorable AdCom vote is an important recognition of Northera’s utility in an indication with a serious unmet need," the analyst said. "However, we believe there are meaningful risks to approval in NOH by the PDUFA date. The vote should be viewed in the context of the negative briefing documents released prior to the meeting, which reflect substantial reservations by at least some members of the FDA."
With or without approval tomorrow, the firm believes Northera approval is achievable in 2012 and the stock is undervalued.
In February, and FDA AdCom voted 7-4 in favor of Northera approval.
Recently analysts at Needham & Company commented on the upcoming decision.
"In our opinion, the favorable AdCom vote is an important recognition of Northera’s utility in an indication with a serious unmet need," the analyst said. "However, we believe there are meaningful risks to approval in NOH by the PDUFA date. The vote should be viewed in the context of the negative briefing documents released prior to the meeting, which reflect substantial reservations by at least some members of the FDA."
With or without approval tomorrow, the firm believes Northera approval is achievable in 2012 and the stock is undervalued.
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