Seelos Therapeutics Inc (SEEL)

[eicoman]

Vitaros only needs to prove safety of DDAIP with the FDA.
Carcinogenic studies on Vitaros have long been successfully resolved.
Only 2 things need to be addressed now with DDAIP: Safety risk to user and partner.

So what do they have to prove Safety risk to user and partner:

1. 2.5% DDAIP risk issues have been successfully addressed resulting in approvals in 29 countries.

2. Conducted several additional supportive pre-clinical studies to address partner safety risk, see 2 studies below that posted on PubMed, not all have been posted. In the EU, part of the partner transference safety approach is in the labeling with recommendations on using a condom with the product in certain instances like oral sex and anal sex.

3. Clinical safety profile from phase 3 studies has not changed with > 1 million uses around the world

Urologia. 2015 Apr-Jun;82(2):84-92. doi: 10.5301/uro.5000116. Epub 2015 Mar 3.
Clinical efficacy and safety of Vitaros©/Virirec© (Alprostadil cream) for the treatment of erectile dysfunction.

Int J Toxicol. 2015 Jan-Feb;34(1):11-5. doi: 10.1177/1091581814561870.
Daily application of alprostadil topical cream (Vitaros) does not impact vaginal pH, flora, or histology in female cynomolgus monkeys.
Meier-Davis SR1, Debar S2, Siddoway J3, Rabe M3.