So, if a development agreement can't be reached with all the "large pharmaceutical companies" mentioned below, because they can't really price in what it's going to take to get SUD001 to NDA, then the Type C meeting that was spruiked in the February newsletter seems to be fairly important to finally get some income into this stock.
So where is it at?
Well assuming that these clowns have actually got around to requesting a meeting with the FDA (and that can't be guaranteed) and the fact that Type C's are scheduled within 75 days - then an update from the circus is now due.
Realistically of all of the value inflection points expected by the end of the quarter only the SUD001 is likely to do something to the share price. Perversely 'value inflection' doesn't translate to share price accretion.
The appointment of a CAB for stiffy-mist will be an interesting read and not much else. It will be a rinse and repeat of the CAB announcement for SUD-001 (which actually has some real talent in drug delivery systems for sumatriptan, migraine management and GSK) but alas no effect on the SP.
Artimist pre-referral plan will all be nicely received by the MMV/WHO behemoth and then some Gate's affiliated do-gooder organisation will commit to about 5 million bucks worth of funding. This will only be enough to allow the next Phase 3 trial to be run out over the next 2-3 years (more waiting for the rainy season in sub-Saharan Africa). Eventually the trial will show more great results and then a couple of years later the MMV will put it on it's list of medicines and potentially 10's of million of spray devices will be disseminated globally.
It's a way away.
This is also the reason why artimist won't be trade-saled there is no economics in it. In fact the out-licencing won't happen in the near future but some very clever writer at SUD will combine the 2nd and 5th 'value inflection' points in the above list together and suggest that the funding of the pre-referral clinical trial is the next best thing.
So that leaves SUD001, FDA and the development strategy to NDA (in 2017). Is it a demonstration of bioequivalence that is required or is it a series long expensive phase2 and 3 clinical trials. Dunno really, this circus has spruiked for a long time the fast track method to marketing approval - I guess now is the test.
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