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doogdilinger

02/08/17 10:31 AM

#23413 RE: wimuskyfisherman #23411

Thanks for your due diligence efforts wimusky!

Samsa

02/08/17 11:34 AM

#23415 RE: wimuskyfisherman #23411

Wim.....Thanks for clarifying this. I do not know which regulation they are referring too, however, I never claimed to be a pharmaceutical lawyer LOL. my background was corporate law and municipal law and then I went to work for a federal agency. (not the FDA LOL) the only law I found, referenced them having to name a manufacturer in order to make the application complete for filing, which I posted. clearly, there are others.

so, this just places us back into uncertainty. which ironically is the focus of the conversation between Fabius and Amigo and myself. the current valuation.

I still side with Fabius on this. we shall see. the point Fabius and I were making is the the illogical price action on the company based on news. No matter what good news is received it adds no value to the company. the only news which did was the the MNK deal and that only marginal. yes, I say marginal because we went from $2.20 to $2.70 BUT those levels which we see today are exactly where we were 1 year ago. so tell me what value it added? then all the good news on top of it and nothing is the point. The nly argument is now "well Rexista is just another Oxy product' well, I counter with one which the company estimates securing 200 to possible 400 million in sales. yet when the company released great news of its studies it had no effect on the price.

Now we learn there may be no pending partnership. technically that shouldn't effect the price as we didn't have a partner a week ago either. we shall see if the price starts to slide and that will prove the argument that Fabius and I are trying to make.

WeeZuhl

02/09/17 9:13 AM

#23459 RE: wimuskyfisherman #23411

That's good dd, wimusky


I received clarification from IPCI in regards to specifying the manufacturer on Rexista NDA. Their position is they do not need to list a manufacturer to receive tentative approval. However, to receive final approval they need to specify the manufacturer.





I am not aware of anyone else getting IPCI on record as expecting only Tentative Approval this review cycle. Can you tell us with whom you communicated, and was there any mention of the company's expectations of the timeline until Full Approval?

Good post, thanks.