the fda will approve the drug when the guidelines are established for distribution of the drug; ie..informed consent for the patient and physician. the capsules will have a marking on them indicating this drug is not for use by pregnant women. also female patients must be on birth control in order to receive this med so more guidelines...so on and so forth so it is a matter of time. this should all occur within a few months. i expect any time now. there is much excietment with the approval and lots of physicians and clinics will try to use the product as soon as it is released and not just for leprosy but the wasting syndrome of aids and cancer. this drug is a great anti-emetic and will alow for weight gain. i have a position and will hold. this company may have assets and products that other pharm. companiens may want. think merger or buyout. this is the year for it.
Considering the fact that this company has such a huge 52 week stock price range (roughly 5 - 13), let's not be overly excited about the anticipated FDA approval. If the approvals don't happen or don't happen within the first quarter, I think you may see the price fall as larger institutional investors bail out. However, I too have a long position and am betting on good news in the near term. Let me pose this question: why are EPS projections so low in 1998? I understand that there are some significant (and diverse)markets if Thalidimide is approved. Why don't the analyst projections indicate this? Is is because Thalidimide is expensive to manufacture? Your insights...please.