One problem with MCU/MPH's timeline is...
that they indicated enrollment should be completed by November of 07... Now given there are 120 facilities involved that's only 25 patients per facility enrolled
and so I would think they complete enrollment much sooner,
say August. Given the trial is 3 months long the data could then be locked by the end of Novemeber and data released 6 months afterwards. Don't forget the problem with Phase2 was that the company doing the analysis for Medicure couldn't even begin analysing the data for atleast 3 months because they were so busy. Yes that's correct, MPH doesn't do the analysis to keep it indepent from manipulation to satisfy the FDA.
If in fact they complete enrollment by the end of November as indicated then they won't complete the trial until the end of February with atleast a 6 months time to anayse the data meaning results at the end of August or beginning of September of '08. The FDA Fast Track status means the FDA instead of taking 9-12 months to analyse the data submitted will take no more than 6 (or less). So February 09 could see the FDA Approval.
Don't forget, as good as MPH is and Dr.Friesen, they have Never met a timeline they've set so the one I posed above is a little more realistic. Given they submit their New Drug Application at the same time as the data for review by the FDA the NDA could then be approved by March or April '09 with the Drug hitting the market by early summer.
Atleast we can be assured that there will be No more Financing requirements.
My hangup with the company right now is that since the PH2 results were released everything else (all other drug trials)were put on hold while Ph3 has been set up so we've lost over a year on everything else moving forward. That's the worst Management strategy I've ever seen.
In the end though there's no question that it will be a SlamDunk.......
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