The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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I can appreciate the confusion, but it's not that complicated.
The 505(b)(2) route is the only way in which ERP can satisfy the fixed-dose combination rule (in essence, that each active is essential for efficacy without compromising safety- the nature of the product means that this cannot be determined separately for lidocaine and prilocaine). The big hope is that the FDA will accept safety through reference to data accumulated for comparable products, actual product safety to be confirmed by a bridging study with a selected reference product.
Clinical data still needs to be generated through one or more pivotal studies, the complication being that the PEBEQ endpoint only goes out to 1 month, whereas the optimal Tx endpoint is 3 months, hence the shift to an "adaptive design". Very intrigued to see what this will look like and how it impacts on label claims.
Cutting through whimsy, there's no cunning plan involving OTC- combination of actives rules out monograph submission. There's no "vast database" of safety or efficacy data (have a read of the full CHMP switch document), only the EudraVigilance adverse event capture. Fortacin was never reimbursed so no filled script tracking, actual usage is unknown. Since the manufacturing process for the 20 dose can has never changed, safety data gathered over a decade ago (and for the more recent Ph II- total of under 300 subjects?) could be included in a US submission.
morning dougie.it would be good to think so and yes the silence does suggest something might be afoot.it's a good point which you and bignose make about the weight of data and with the 505(b)(2)route they can use data from sources other than themselves,which may be part of the plan.lots of questions!!
They must be upto something like this behind the scenes , there must be a left field tactic they are going after . Hopefully sooner rather than later it is realised . There has been enough data to show the product is safe and effective .
morning bignose.yes interesting article.we seem to have entered some rather cloudy waters now,with the reference to the RLD protocol and trial.i have spent some time (yes i know i should get out more) trying to work out why they re now trying to do,but(no surprise)failed to come to any real conclusions,as i don't have the technical industry knowledge and understanding which would help and of course ,we have not been given much to go on by ERP itself. i'm hoping the next operations update will clarify exactly what the new strategy is.the article does suggest a movement in favour of OTC,which of course was exemplified by our own success in that respect,but whether this can be incorporated in some way in other regions only time will tell.fingers still crossed!
Morning chaps.
Pretty quiet here of late even with the sp bouncing around on miniscule volumes producing large % swings.
Although the article is from Sept 2020, it may be of some interest since it cites our product at the beginning of the discussion. ====>>>
https://klinegroup.com/embracing-rx-to-otc-switch-japan-and-europe-foster-access-to-nonprescription-medications-but-will-that-have-an-impact-on-the-united-states-market/
What is interesting is that the FDA (Janet Wood**** (director of the CDER) - a very appropriate name when considering the likes of ED) do not dismiss the possibility outright. See the 5th paragraph regarding the Frederick Mayer petition and Janet's remark "if a medication is appropriate, effective, and safe for them to use, there could be increased switch activity in the United States as well" PLE certainly have a vast database of subjects who have used the product with next to no side effects.
I wonder if any of this is being discussed with the FDA/Japanese and possible Licensees ????? Food for thought ?