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Plethora Solutions Holdings PLC Share Chat (PLE)



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Alquemie
Posts: 1,014
Opinion:No Opinion
Price:0.00
RE: Recordati
Fri 14:21
All very curious....

Fortacin has been listed in the Greek and Romanian national formularies for months, and, as in the other territories, with a urology sales force already in place, it could have been launched at very modest cost. Minuscule sales have never prevented the promotion of other portfolio products (Vitaros, Kentera, Urispas and other "for show" details).

And for a promotion sensitive product such as Fortacin, postponing launch in countries with a field force in place while perhaps launching in the the hardest market of all (no sales presence, no urology portfolio, NHS blacklisting, lowest per capita specialist representation), with the only viable option being remote prescribing and supply either directly or through a third-party), marks a strange shift in strategy.

Complete speculation on my part, but I'm aware that Recordati have recently received approval for a Urorec generic in the EU and while they have indicated an expectation of continued modest growth (largely in ex-core territories), I'm wondering whether they are looking to close out the urology franchise (at least in developed markets) early to focus on higher margin specialities.
 
bignose58
Posts: 2,028
Opinion:No Opinion
Price:0.00
RE: Recordati
Fri 12:52
Montezrevenge,

You are certainly right there, but then. Since a promise is a declaration of something to shareholders or a shareholder etc, then it can be considered as reneging. Anyway, the pont is they, like RP, are not following their statements of timed events.

Since the transfer of marketing etc to Recordati, RP has no longer any say in the matter. What is more interesting is whether RP is keeping tabs on what Recordati are doing. Surely there has to be some continued follow up. And although you are correct that RP don’t need to keep the market or shareholders updated, they did make the statement on follow up launches in h2 of 2018 which was made at the same time as the disappointing sales statement.

It seems to me that they are not following up and probably appreciate the news from outside that launches have been delayed from those stated. I Honestly thought after all these years things would now be different as the product is out there. Apparently not and shareholders are again left to wonder what’s going on. As stated, the UK launch may get even further delayed since credibility on launch dates is now questionable.

Anyway, I await any response from JG who I am sure will provide a perfectly good explanation..... ;-)
Montezumarevenge
Posts: 11
Opinion:No Opinion
Price:0.00
RE: Recordati
Fri 12:18
I would be interested to hear what RP has to say but I do not regard Recordati as having reneged on anything as that implies a range from a contractual obligation to a simple promise. Recordati simply provided guidance on their intentions but they are at liberty to change these intentions at any time, including the extreme case of abandoning a launch territory altogether.

I expected a delay as the launch, as the E5 has demonstrated a need to increase awareness, so little point in launching into a vacuum. As for RP's silence on the delays, do we really want RP to announce what is pretty insignificant news in the bigger scheme of things to the market and which of course be misunderstood by the same as a huge negative.

I am more exited by the prospect of Fortacin being launched in the UK, it is almost certainly a potentially much larger market than Greece, Poland, Romania, CR & SR put together particularly when one considers the likely price point.

I have always been very surprised that Recordati did not have the UK higher on its list, or indeed another partner lined up if Recordati's lack of a sales force was a barrier to entry which all of a sudden no longer seems to be the case.

I think awareness in the UK is likely to much greater than the smaller territories so am positive about commercial prospects.

In regard to ROW licenses, the interims referred to PRC being in advanced active discussions whilst the ROW were in active discussions- a subtle but nevertheless important difference. I can bot see anywhere where its says that further EU launches will assist with ROW licenses. although I could have missed that.

I think the Fosun license should be a much stronger driver in that were true.
The.Italian
Posts: 533
Premium Chat Member
Opinion:No Opinion
Price:0.00
RE: Recordati
Fri 09:25
good afternoon Bignose.yes looks like you were spot on about further EU launches.we will just have to wait and see what happens with uk but even if its not a major target area it would be good for board morale here to see it relaunched here.havent had a chance to check out what was said re ROW launches but i think you are right. may try and look back over announcements later today if i get the chance

will be very interesting to see what reply you get from jamie
bignose58
Posts: 2,028
Opinion:No Opinion
Price:0.00
RE: Recordati
Fri 00:27
Morning The.Italian.

Thanks for the feedback.

Exactly what I hypothesised that Recordati would delay further EU launches due to their "dissapontment in sales". What were to be Greece, Romania in Sept 2018 and Czech rep, Slovakia & Poland in Dec/Jan 2019 are now delayed indefinitely (since they can provide no dates). Interestingly they now state that the UK will be relaunched in Jan ....... Or will it ? I guess they cannot really say since they have now "reneged" on the other 5 EU launch dates.

Will this delay possibly impact progressing the ROW licenses since wasn't it announced that the ROW licenses would depend on the EU launches or am I miss quoting ?

Although the delays don't surprise me, it certainly contradicts the statement made in the unaudited interims announcement. "The Group is continuing to work closely with Recordati towards the planned commercialisation of
Fortacin™ in Greece, Romania, Czech Republic, Slovak Republic and Poland in the second half of 2018"

I have emailed JG for clarification since he surely is not aware otherwise he would have advised the market........"NOT"...lol
The.Italian
Posts: 533
Premium Chat Member
Opinion:No Opinion
Price:0.00
Recordati
Thu 21:39
had reply from Marianne Tatschke at recordati investor relations. produced verbatim as follows:

"Fortacin has been launched in Italy,Germany ,Spain ,France and Portugal.To be launched in UK in January 2019 and after that in Greece Romania,Czech rep,Slovakia and Poland.Dates not available.
yours"

at least its positive info re uk.not sure about the rest of it.
Bothwell
Posts: 271
Opinion:No Opinion
Price:0.00
RE: Up
Wed 16:19
Let’s hope so...... I have the patience of a Saint!!!!
Keithbfk
Posts: 95
Opinion:No Opinion
Price:0.00
RE: Up
Tue 14:40
Continued steady rise in share price would make for a very happy Xmas. GLA. It's been a bumpy ride.
bignose58
Posts: 2,028
Opinion:No Opinion
Price:0.00
RE: Up
Tue 09:30
Bothwell,

Maybe this is the turning point. With a major Chinese license now in play which is far larger than the Recordati one with a huge population size, maybe investors are starting to take notice and realise the significance. Its going to be a continued spread of information which should be exponential. I am sure those that get in now will not regret it.
Bothwell
Posts: 271
Opinion:No Opinion
Price:0.00
Up
Tue 08:57
Nice 7% today.
Alquemie
Posts: 1,014
Opinion:No Opinion
Price:0.00
RE: US study delay
Mon 15:13
Might be more than three years, as I've assumed an almost immediate turnaround from the COA division, no Type C meeting request and minimal delay in pivotal study site set-up. Possibly safer to add another 6-12 months.

I've assumed a single pivotal study, although as a new indication, the FDA might require two studies. Back of envelope stats calculation gives a minimum of 250-300 subject (couples) recruitment, but could be greater depending on the robustness of the PEBEQ instrument. I'd also expect a Type B meeting before NDA submission, which might add on another three months, and I've made no allowance for further clinical input (combination justification, any additional extended dosing tox,or for bridging studies if change in manufacture).

As to the BOD report card, since they are incapable of making a credible estimate of the PDUFA date, negligence and incompetence are reasonable accusations, as is "misleading", whether by design or not.

Looking back through my diligence notes, since end 2014, the anticipated US PDUFA date/launch has been variously stated as Q1 2017, Q2 2018, Q1 2019, Q4 2019, the last from the October 2017 company presentation. Approval timelines do change, but it takes talent to be so consistently wrong.

I've been transparent in my timeline estimate- why not ask the BOD to share their own assumptions?
The.Italian
Posts: 533
Premium Chat Member
Opinion:No Opinion
Price:0.00
RE: Recordati
Mon 10:46
bignose thanks for that very helpful.i will do as you suggest.i prefer tailor made enquiry anyway so you can keep a copy.probably do it tomorrow as on grandson minding duty later today
bignose58
Posts: 2,028
Opinion:No Opinion
Price:0.00
Recordati
Mon 10:30
The.Italian,

I too used that form and had a response from Marianne Tatschke who I understand is in charge of investor relations.

My response email came from here => investorelations@recordati.it , which you could try and email directly and address to the above. I would suggest you state you also have a small holding in Recordati. No proof of purchase is required..... ;-)
The.Italian
Posts: 533
Premium Chat Member
Opinion:No Opinion
Price:0.00
RE: Recordati
Mon 10:18
Bignose i did say that i held shares in regent but i didn't say recordati which perhaps would have helped even though untrue .i did use the pre formatted investor enquiry facility which was perhaps not the best approach as a tailor made enquiry might have been better on reflection.i will try again later this week but as you say they are not major events in the overall scheme of things.much more to come hopefully from USA china and interms of investor awareness HK and Macau
bignose58
Posts: 2,028
Opinion:No Opinion
Price:0.00
Recordati
Mon 09:44
The.Italian,

Interesting since they normally do respond (Did you mention you held shares in both Recordati and RPG. ;-) ).

Maybe the launches have not happened given that their contribution is small (Romania 2.5mill and Greece 1.4 mill => 1 in 4 male sufferers), which I alluded to after the announcement of Recordati being disappointed. I guess we will find out in the year end results which should also include Poland/Czech Rep and Slovakia.
The.Italian
Posts: 533
Premium Chat Member
Opinion:No Opinion
Price:0.00
RE: Recruiting
Mon 09:00
obviously my propensity to suffer auditory hallucinations is increasing with my age!still good news either way.incidentally i had no response from recordati to my e mail sent around the 22nd Nov re progress on the other expected roll outs.i may try again later this week.
bignose58
Posts: 2,028
Opinion:No Opinion
Price:0.00
RE: Recruiting
Mon 08:44
The.Italian....hear what ? Mind you, I did just read something about it....LOL
The.Italian
Posts: 533
Premium Chat Member
Opinion:No Opinion
Price:0.00
RE: Recruiting
Mon 08:38
good to hear at last!
bignose58
Posts: 2,028
Opinion:No Opinion
Price:0.00
Recruiting
Mon 08:21
Finally, the https://clinicaltrials.gov/ct2/show/NCT03578783 website is now showing "Recruiting". Onwards and upwards.
Bothwell
Posts: 271
Opinion:No Opinion
Price:0.00
RE: Just been looking back @ ii posts
Sun 15:56
Because it is all going to plan!!! Ok over the next 2 years!!!
ripley94
Posts: 95
Opinion:No Opinion
Price:0.00
RE: Just been looking back @ ii posts
Sun 15:08
About 8 pages of posts since my last one here.
This was 0.23 then... now back up to 0.36 ( more then 50% up ) any reason ?
see it was 0.46 in July just gone., 0.68 this time last year ( 2nd Dec 2017 )
bignose58
Posts: 2,028
Opinion:No Opinion
Price:0.00
RE: US study delay
8 Dec '18
I think you mean Mr Mellon since JG was brought onboard after the event.
Montezumarevenge
Posts: 11
Opinion:No Opinion
Price:0.00
RE: US study delay
8 Dec '18
Bunion- have some sympathy for the old fella - the commencement of prime time advertising of Viagra as a non prescription treatment has hit him pretty hard. He was not expecting it until 2050 earliest, if at all.

Should not be that long in pharma timeframes before Fortacin goes the same way. May even end up side by side with Viagra in vending machines ! RP must be on radar of suitors with a vision of the future.
Montezumarevenge
Posts: 11
Opinion:No Opinion
Price:0.00
RE: US study delay
8 Dec '18
I gather you are no fan of Mr Gibson and his decision making prowess but even you must concede that his decision to remove the former CEO of Plethora Solutions was a stroke of pure management genius.

Look you have added the best part of three years to the RP BOD indication of the expected time frame to get to PDUFA. You like to make all sorts of inferences and slurs but are never man enough to call it as you see it. Surely if the BOD is three years out they are either negligent, incompetent or guilty of misleading shareholders ? Which is it in your view?
bunion
Posts: 363
Opinion:Strong Buy
Price:0.00
RE: US study delay
8 Dec '18
Of course much of what. Alq spouts is just negative nonsense. Note that Alq, an ex Plethora employee holds a big grudge against the company...so whenever we have some really good news, he suddenly appears with his own negative version of events.......so what Alq says should be taken with a tonne of salt.and he's not even a shareholder!
With a China pharma now on board, Regent Pacific is looking a ver attractive investment.




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