What's Next for Protalix BioTherapeutics Shares Fall After FDA CRL?

Steven Breazzano submits:

Long investors in Protalix BioTherapeutics (AMEX: PLX) awoke Friday morning to a press release announcing a CRL (Complete Response Letter) from the FDA. While the stock immediately sold off to the mid 6?s before recovering to mid 7?s (a 19% discount to the previous closing price), investors are left asking, ?What went wrong?? Reading over the press release, the FDA appears to be concerned over two issues: CMC (chemistry, manufacturing and controls) and clinical. Directly from the press release:

In the clinical section, the FDA requested additional data from the Company's switchover trial and long-term extension trial. At the time the NDA was submitted, full data from these trials was not available. In the CMC section, the FDA requested information regarding testing specifications and assay validation.

Fortunately for investors, the FDA did not request long-term studies, and following a meeting with the FDA to ascertain exactly what needs to fixed,

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