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Re: eicoman post# 27147

Monday, 03/20/2017 3:34:40 AM

Monday, March 20, 2017 3:34:40 AM

Post# of 30350
Eicoman

Your response while well intended - is a good example of what I was expressing in the post you responded to. We want to concentrate on the reward but leave the necessary costs to get to the FDA approval out of the equation ( and we aren't even talking numbers here yet ).


I would agree this company has been dismal on execution, but they have done work, and the work on the USA Vitaros FDA submission is complete when the OPQ issues are addressed, they have had lots of FDA feedback on all other issues. An FDA re-submission is always a 6 month review, not 10 month like original submissions.


Let me share a somewhat similar scenario - in regards to NDA and NDA resubmissions - of another company I follow. Adamis Pharma

I will try to make it brief:

-May 29, 2014 - NDA submitted to the FDA

-July 29, 2014 - FDA accepts for review the NDA

-March 27, 2015 - FDA responds with a CRL ( complete response letter ) - Questions regarding CMC. No safety or efficacy concerns.

http://ir.adamispharmaceuticals.com/phoenix.zhtml?c=99350&p=irol-newsArticle&ID=2056543

-December 07, 2015 - NDA resubmission to FDA in response to CRL - resubmission is intended to address the issues raised by the FDA.

-January 14, 2016 - FDA acceptance of resubmission. The FDA indicated that it considered the resubmission to be a complete, class 2 response to the CRL, and provided an agency new action date of June 4, 2016.

http://ir.adamispharmaceuticals.com/phoenix.zhtml?c=99350&p=irol-newsArticle&ID=2129456

-June 06, 2016 - FDA responds with another CRL - Because of the improvements that were made to the PFS ( prefilled syringe storage ) in response to the FDA’s original CRL dated March 27, 2015, the FDA indicated that in order to support approval of the product, the Company must expand its human factors study (patient usability) and reliability study (product stress testing), both of which were part of the final PFS NDA.

http://ir.adamispharmaceuticals.com/phoenix.zhtml?c=99350&p=irol-newsArticle&ID=2175190

-December 16, 2016 - NDA resubmission to FDA in response to second CRL ( complete response letter ).

http://ir.adamispharmaceuticals.com/phoenix.zhtml?c=99350&p=irol-newsArticle&ID=2230348

-January 19, 2017 - FDA announces acceptance of resubmission of the NDA - The FDA indicated that it considered the resubmission to be a complete response to the CRL.

http://ir.adamispharmaceuticals.com/phoenix.zhtml?c=99350&p=irol-newsArticle&ID=2238418





Adamis Pharma has filed an NDA, and has now filed 2 resubmissions to the NDA. Both resubmissions have been deemed complete by the FDA.

Compared to Adamis Pharma ( which is having ongoing dialogue with the FDA - due to the NDA submissions and resubmissions ) - do you think that the Type B meeting that Apricus had with the FDA back in November would constitute a reasonable positive risk/reward scenario of getting it right the first time around ( of course I am talking about resubmissions )?

In other words, just how deep do you think the FDA dove into Vitaros during the Type B meeting? Deeper than actually reviewing it for approval ( as is the case for Adamis' drug delivery syringe )?

And if a Type B meeting is less detailed than a NDA review. How can you gauge what the near term outcome will be? In other words, will it have enough to be approved "as is" on the second try? Will the OPQ ask for something else prior to the FDA resubmission?

I think Vitaros will be approved - at one point or another by the FDA. The problem is the risk/reward profile that the company presents at this time. What are the necessary costs to get it approved? Something that nobody wants to talk about. And if for some reason it's written about, it's always in best case scenario terms.

Good luck





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