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Re: Investorr post# 122374

Wednesday, 02/10/2016 9:32:56 AM

Wednesday, February 10, 2016 9:32:56 AM

Post# of 130502
Possibly as a way to garnish more attention from Big Pharma companies to gain partnership. If you remember, Elto Trials were set to start running, and a PR was even announced when the first patient was enrolled. Then when there was realization that with ODD, more benefits can be gained before the successful completion of the Phase 2B/III trials. Elto has already been given to more than 600 patients with no significant side effects, so the trial is more of a paperwork drill to show efficacy and tolerance more than anything, and with a proof of concept that has already been done, the trials would go smoothly.

Point is, with ODD designations, it shows that the FDA is on board, and it provides a 7 year Exclusivity period against competition...as well as possibilities for funding from grants tax credits and waiver of PDUFA fees.

With FDA endorsement, the trials will be commencing again soon...I have thought all along that they never should have stopped the trials, but with an agreement for funding from the Army and Rutgers for ESS, it allowed time to reevaluate the rest of the pipeline. I am guessing that as soon as trials start up again, there will be information coming out about paring MANF from the recent hiring of the WallachBeth firm.

Just my two cents...
This may be the beginning of the turn around...
I guess we shall see when the 16th rolls around to see how many more shares the Toxics convert.
In My Own Personal Opinion Of Course!
Long AMBS!

In My Own Personal Opinion Of Course!