Replies to post #4253 on Seelos Therapeutics Inc (SEEL)

[MasterMerlins]

Markkind- The PreVonco SPA Discussion with the FDA has been ONGOING for well over a Year..! My understanding is that it's a Back and Forth, "Tug of War" if you may.. Between the FDA and Apricus.. They have to Agree on ALL Points..! Primary Endpoint and Secondary Endpoints.. What is to be Considered Standard of Care and what will PreVonco Results be Measured Against.. It's a Bunch of Stuff..

I read his post on Yahoo.. I believe that it is not NEW Information.. The Article might be NEW.. But, the Information in the Article is NOT..! It talks about 12-24 Months but that is how long the Phase III trial would take.. Which by the way.. Is just an Estimate because the Trial Duration and Size is being Finalized during the Spa Talks with the FDA..! It's not final information.. As of YET..! Not until they Both AGREE..!

My understanding is that Apricus is First going to run a SMALL Phase I BioEquivalency bridge trial, sometime in this 2Q..!
They are going to Incorporate NexAct with Lansopropazole..

You have to Remember that PreVonco came from what is now Innovus..
They did not have Access to the NexAct Technology.. PreVonco had received Orphan Drug Status without it having NexAct incorporated with it.. ( By the way, It having or it not having NexAct does not have anything to do with the Orphan Drug Status )..


Anyways.. You cite lack of Cash as an Issue.. Answer would be YES.. But, now that they do have the CASH.. They are running the Phase I which should not cost much to run.. And then .. Once they have the Finalized Agreement for the Phase III SPA Trial.. They will start with all the Logistical Aspects that are needed to be put in place before the Commencement of this Trial..

And let's not forget that the Original Plan of the Company.. Was not to RUN Full Clinical Trials on their own.. It was to Position EACH Drug Candidate.. So that the Clinical/Regulatory Pathways were Defined and then look for Partners willing to help them pay or share costs in the Trials.. Of course.. There is no Guarantee that any Company will Partner and pay for Costs for Sure..

If you think about it.. Femprox is ahead in many aspects in relation to PreVonco.. The only thing that Femprox is behind in. Is that they still have to submit the Phase III Protocol to the FDA for it.. But, in a WorldWide Sense.. Femprox is Ahead..!