>> Can you hypothesize an "if everything goes well" timeline for Squalamine after a partnership announcement through Phase III, NDA filing and final approval for AMD? <<
Assuming an AMD partnership is consummated soon and the companies opt to proceed directly to phase-3 trials, FDA approval could come in late 2006 or early 2007.
Figure on late 2Q04 for completion of an FDA review of the phase-3 protocols and issuance of an SPA (#msg-1604114), followed quickly by the start of patent enrollment.
Allowing six months for enrollment, the last patients would begin treatment by the end of 2004. One year of treatment (the minimum for FDA approval in AMD) would run until the end of 2005, so an NDA could be filed in 1H06. With a six-month priority review (likely, but not automatic), the FDA could act by late 2006.
This schedule is pretty tight, so FDA approval could slip to early 2007 even under the general framework assumed above.
Add at least 9-12 months if GENR and partner opt to defer the start of phase-3 trials until evaluating the outcome from an additional phase-2 study to test variations is dose scheduling. This would push approval out to late 2007 or early 2008.
Lest you get discouraged by the slowness of the path to approval, bear in mind that our big payday as investors may come much earlier :-)
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