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Biotech / Medical : Apricus Biosciences -- Ignore unavailable to you. Want to Upgrade?

To: phoenix_rising who wrote (1821)

4/6/2016 3:34:03 AM

From: Mirror Image

Read Replies (2) | Respond to of 2026

The FDA asked for certain studies to be performed- the last time that they had communication with Nexmed and also had issues with the manufacturing of Vitaros ( it was manufactured by themselves back then ).

A press release noting the deficiencies that the FDA found in Vitaros back then can be found in the link below.

businesswire.com

A summary of the key regulatory concerns and agreements by the participants is as follows:

1. Overall Carcinogenicity Assessment: The Division has agreed to NexMed's request for a review of this assessment by the Carcinogenicity Advisory Committee (CAC) prior to NexMed's Class 2 resubmission in reply to the Action Letter. The CAC will review NexMed's briefing package, which includes the results from its three, two-year carcinogenicity studies in mice and rats, and determine whether the new weight of evidence can alleviate the FDA's concerns over the positive results from the TgAC (transgenic mouse) study. NexMed plans to submit this briefing package for CAC review by the end of the year.

2. Assessment of the transfer to the partner of NexMed's NexACT(R) technology: The Division concurs with NexMed's proposal to conduct one Phase 1 study in healthy volunteers, with the design of the trial to be determined.

3. Assessment of transmission of sexually transmitted diseases (STDs): The Division concurs with NexMed's proposal to conduct one animal study, with the animal model to be determined.

4. GMP (Good Manufacturing Practices) Status of NexMed's manufacturing facility: NexMed has adequately addressed the deficiencies cited in FDA's Pre-Approval Inspection and the FDA has revised the status from "withhold" to "acceptable."

As far as I know there was another Carcinogenicity study performed by Warner Chillcott in 2009 or so.

All of the above were the reasons the FDA found Vitaros non-approvable back in 2008. Vitaros was not approved anywhere in the world back then. So, it seems that they were also cautious about the effects of Nexact. Vitaros has been approved by two different Regulatory Agencies since. Is now in the market in Europe ( as you know ). So, with all the data that Apricus now has been able to gather - through the years - while dealing with the two different Agencies - on top of now - real market data - in regards to end users. I see a very good chance of them having what is needed for the FDA to make a decision on Vitaros.

Can the FDA ask for another trial? I'm sure it can! The question would be: Will the FDA ask for another trail and what would be the reason for it?

I know the sentiment in regards to Apricus is at a very low point. I myself could not submit posts on this Board at the beggining of last week because I had nothing good to say. But I will say this. Fispemifene or no Fispemifene - Apricus / Vitaros is worth more than 63M ( today's Market cap 36 M ).

Can they keep the share price down here? YES. Will they?

I have ran the different scenarios through my head - as far as 30 days under $1. We receive Nasdaq notice and go on a 180 day timeframe to maintain a $1 bid for 10 days. Then ask for the ONE extension for another 180 days to get the price up to $1. If my math doesn't fail me. That should put the company in a tough spot by around MAY 2017 ( reverse stock split spot ).

I doubt Sarissa would let it get to that point. Like I said in my earlier post, Sarissa appointing a Director to the Board should be enough to get the share price trending positive. Add some Denner comments on looking to get a fair price for the company. Some have asked - what about his $.88 buy ( if it was for Fispemifene ). Do you think - if they were to put the Company up for sale - Sarrissa wouldn't at least their Investment?

For those of us with a higher average - if it gets to this - we might not get our Investment. But I do think we will get more than .63 for every share we own.

Going back to the MAY 2017 date. If they were to resubmit the NDA for Vitaros by September 30, 2016. The decision should be back from the FDA by the end of March 2017.

I know you will point to Management's track record - as far as delivering on time-lines. And I agree. I have nothing to counter your point. I only hope that Denner gets on the offensive and starts pushing these people publicly ( and a very public way would be - add a Director to the board ).