Tuesday, June 27, 2006 11:21:16 AM
rstor, I have to agree on the pps effect.
As much as I love the solid science in the Endo 2006 presentations, I think the overall market cares not too much. The diabetic/SIR indication is exciting but not a fast path, and the current estimate out there that there are only ~2,000 SIR patients in the US makes this indication difficult to justify NDA-level investment. I would hope INSM intends to negotiate a broader definition of SIR before proceeding. My guess is that pivotal trials supporting FDA approval in any diabetes subpopulation probably can't be completed/submitted for at least 12-18 months.
Serious numbers of investors outside those that have already discovered INSM will be needed to power pps above the mid-$2 area in a sustainable manner. Such new investors will not be noticing much until the hard data of bigger revenues starts to be reported. Or any resolution of the remaining lawsuits. Or news that BP3 for adjunct use in cancer chemo had moved ahead in some important way. That would really raise & reshape the company's profile.
I don't expect any bigger movement until end of 06/early 2007 based on IGFD - when the INSM v TRCA commercial competition will have started to take long term shape. A noticeable pps move could come if INSM announced filing another NDA or amendment to current NDA based on other indications. That would be important because it would move INSM out from under from the scope of at least the '151 lawsuit from TRCA. MMD and Aids Lipodystrophy may be leading that race, but I would expect NDA filings not to be possible on those until mid-late 2007 at best.
This company's longer term expansion rate will not be easy to estimate until 2008. Long road but excellent prospects.
regards
As much as I love the solid science in the Endo 2006 presentations, I think the overall market cares not too much. The diabetic/SIR indication is exciting but not a fast path, and the current estimate out there that there are only ~2,000 SIR patients in the US makes this indication difficult to justify NDA-level investment. I would hope INSM intends to negotiate a broader definition of SIR before proceeding. My guess is that pivotal trials supporting FDA approval in any diabetes subpopulation probably can't be completed/submitted for at least 12-18 months.
Serious numbers of investors outside those that have already discovered INSM will be needed to power pps above the mid-$2 area in a sustainable manner. Such new investors will not be noticing much until the hard data of bigger revenues starts to be reported. Or any resolution of the remaining lawsuits. Or news that BP3 for adjunct use in cancer chemo had moved ahead in some important way. That would really raise & reshape the company's profile.
I don't expect any bigger movement until end of 06/early 2007 based on IGFD - when the INSM v TRCA commercial competition will have started to take long term shape. A noticeable pps move could come if INSM announced filing another NDA or amendment to current NDA based on other indications. That would be important because it would move INSM out from under from the scope of at least the '151 lawsuit from TRCA. MMD and Aids Lipodystrophy may be leading that race, but I would expect NDA filings not to be possible on those until mid-late 2007 at best.
This company's longer term expansion rate will not be easy to estimate until 2008. Long road but excellent prospects.
regards
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