With Relistor being a successful product that has decent upside in sales, it will make PGNX a different company in the eyes of investors as it will have real earnings. This would go along ways to get the shorts out of the weekly beatings the share holders are currently experiencing.
To your point about the change in 1404 strategy, if they decide to go it alone, they need to change the board membership to bring in professionals that are experienced in building infrastructure, marketing and sales...then they need to build partnerships with medical products manufacturers. In my view, PGNX would have to be a very different company.
Thanks for your input / thoughts.
If the cost to commercialize 1404 is approx. $4MM, why sell Relistor? They don't need the money. You only sell a cash cow if it is a very good deal. I mean a very GOOD deal.
So, is the cost to commercialize 1404 hugely more? Wouldn't Relistor oral sales cover those? I mean of course the commission structure. This company has good technical mgt and BOD. If they sell Relistor for a significant amount, then they will also need to change the executive staff and BOD. Selling Relistor, getting 1404 launched and commercialized means selling PGNX to a big corp that can run it effectively. Good for the current stk holders if they stay in the stk. Last comment in reverse order, Baker could of said more to the analysts about Valeant sales force numbers AND 1404 commercialization without violating SEC laws. He could nuance his statements. He was not prepared.
If everything happens per the CHMP - Relistor summary, we should see the Relistor approval by Monday, June 22nd. That's 67 days after the positive opinion issued by the CHMP on April 23rd.
Thanks for your insights and the overall potential of 1404. I'm not a scientist and have a limited understanding of 1404 at this time. I will do more research to better understand this . I needed a baseline to get a realistic starting point.
Baker needs to better prepare for the CC Q&A. He knows where the analysts are going to focus, just like the rest of us who have invested. If he had answered the 1404 questions as you have summarized, I would be comfortable with his public display of guidance and leadership. He needs to put those data points in place and let the analysts do the rest.
Again, thanks for the summary.
What's your estimation to get 1404 to the pt where it can be a commercial offering?
I want to do a quick cash analysis to see what it takes to get there.
The call with Baker yesterday was as if he was reading from a prepared script. Nothing new. Nothing. In an of itself that isn't all that bad, but, you could tell that some of the analysts were looking for updates to then go out and promote PGNX. Baker gave them nothing. To not know how many Valeant sales people are out there pushing Relistor is ignorant or just stupid on the part of Baker. Surely, he has asked Valeant. He said they have met and discussed their strategy going forward. Valeant says they are keeping the Salix sales force, then they also state they are going to double the pain sales force. Baker claims to know very little about this.
The steps to commercialize 1404 also got my attention. Baker states that PGNX will probably have to got it alone. No interest currently from big pharma, ok, I got that, but there must be other global corps that would love this kind of partnership opportunity.
Why not be prepared for the obvious Q&A from the analysts? You know they are going to ask about Valeant focus in the near term and drill into that and what it means.
Really disappointed in Baker's performance yesterday. He better step up his game in a big way for the next call. I hope he gets roasted at the annual shareholder's meeting.
Here is a portion of the VRX update from their earnings call referring to Relistor activities:
Next, we have established a new sales force to provide greater attention to the pain community, promoting Relistor and other Valeant brands such as Migranal and Bupap. We expect significant revenue synergies to Valeant products which have historically not been actively promoted to either hospital, government entities, such as the DoD or pain specialists.
I'm betting that label expansion gets approved. I think there is more good news to come in the next months. This summer for PGNX share holders will be rewarding, IMO.
Here's what I saw posted this morning.
Mechanism of action: Relistor Methylnaltrexone (Sq), a SM-inhibitor, relieves the side effects associated with prolonged opioid exposure by blocking peripheral mu-opioid receptors with a methylated (unable to cross the BBB) version of the known opioid receptor antagonist naltrexone.
Phase of Development: Filed
Event Type: Regulatory EMA: CHMP Opinion (Estimate)
Seems that a lot of retail investors are sitting on the side lines today in anticipation of the update from Baker tomorrow. I really want to understand the relationship with Valeant and how Baker is going to pushing the PGNX agenda forward.
Mark R. Baker, CEO, is scheduled to present at the 14th Annual Needham Healthcare Conference on Wednesday, April 15, 2015, at 2:20 p.m. Eastern Time.
Here is what I got from PGNX I.R. this morning as well. Same topic/question. I asked for an update on the EMA-CHMP Relistor extension review.
Thank you for your inquiry. We expect to be able to provide an update within the next month or two. If you have any further questions, please send me an email or give me a call at the number below.
I received this correspondence from the EMA this morning.
Re: ASK-11197 Relistor approval received on 1 April 2015
Thank you for submitting your request.
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We endeavour to provide a response to all information enquiries (RFI) within 2 months according to The European Medicines Agency Code of Good Administrative Behaviour.
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