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Sunday, November 06, 2005 7:38:08 PM
DewDiligence - Clinical-trial / regulatory calendar
By about mid-December it's not only the routine do or die for SCLN as a small cap biotech but there are suddenly more than one of many big items hitting the wires.
I thought about adding SCLN to your regulatory calendar but as new kid on the block I was not overly eager to add another "HEB" to the list. (Obviously I have others that some here might consider in a class with HEB or worse.
)
By about mid-December SCLN will report the results of the topline analysis of the first of the crucial HCV trials. The second will be due within 6 months. A Phase II melanoma trial that may have caused the Cavazza brother to buy 23% of the O/S will report. News on progress of the pegylation formula for Zadaxin that will give SCLN worldwide composition-of-matter patents will be first reported. A Phase II liver cancer trial that some think the biggest of all will report in. Oh yeah, the incredible screw-up with SGP-Japan losing data from a Japanese pivotal trial that prevented an NDA for treating HBV as monotherapy may complete mediation about that time frame or go to arbitration.
The timing is so conspicuous that there is rampant speculation that it has to do with the due date for a convert and warrants on the 19th of December. (Black helicopters, anyone?)
I am not normally real big on timing but all this seems to have the potential of a supernova in both senses. As you know a supernova is not just a spectacular but essentially the death of a star as well.
All just in case anyone is interested in an old timey bad boy with a bad rep for very good reasons in the past.
My persuasion is that new scientific evidence and a wealth of data now supports a drug that previously had none. Bad old management has flown off on golden parachutes.
Best, Terry
By about mid-December it's not only the routine do or die for SCLN as a small cap biotech but there are suddenly more than one of many big items hitting the wires.
I thought about adding SCLN to your regulatory calendar but as new kid on the block I was not overly eager to add another "HEB" to the list. (Obviously I have others that some here might consider in a class with HEB or worse.
) By about mid-December SCLN will report the results of the topline analysis of the first of the crucial HCV trials. The second will be due within 6 months. A Phase II melanoma trial that may have caused the Cavazza brother to buy 23% of the O/S will report. News on progress of the pegylation formula for Zadaxin that will give SCLN worldwide composition-of-matter patents will be first reported. A Phase II liver cancer trial that some think the biggest of all will report in. Oh yeah, the incredible screw-up with SGP-Japan losing data from a Japanese pivotal trial that prevented an NDA for treating HBV as monotherapy may complete mediation about that time frame or go to arbitration.
The timing is so conspicuous that there is rampant speculation that it has to do with the due date for a convert and warrants on the 19th of December. (Black helicopters, anyone?
) I am not normally real big on timing but all this seems to have the potential of a supernova in both senses. As you know a supernova is not just a spectacular but essentially the death of a star as well.
All just in case anyone is interested in an old timey bad boy with a bad rep for very good reasons in the past.
My persuasion is that new scientific evidence and a wealth of data now supports a drug that previously had none. Bad old management has flown off on golden parachutes.
Best, Terry
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