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Plethora Solutions Holdings PLC Share Chat (PLE)



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Bothwell
Posts: 267
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: 91
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: 2,021
Opinion:No Opinion
Price:0.00
RE: US study delay
Sat 22:02
I think you mean Mr Mellon since JG was brought onboard after the event.
Montezumarevenge
Posts: 10
Opinion:No Opinion
Price:0.00
RE: US study delay
Sat 18:03
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: 10
Opinion:No Opinion
Price:0.00
RE: US study delay
Sat 17:51
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: 362
Opinion:Strong Buy
Price:0.00
RE: US study delay
Sat 14:54
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.
Alquemie
Posts: 1,012
Opinion:No Opinion
Price:0.00
RE: US study delay
Fri 18:06
I'm stating that a PDUFA date in 2021 is a nonsense and not assigning a reason or motive.

As for " a little tight", given timeline allows only 12 months for the pivotal study and NDA submission, potential for a spot in the Guinness Book of Records.

And speaking of the black stuff, it's well past beer o'clock.
Montezumarevenge
Posts: 10
Opinion:No Opinion
Price:0.00
RE: US study delay
Fri 11:12
Although the completion of the P2 and commencement of P3 appears a little tight, there is nevertheless a substantial time line and process disconnect to your presentation. Are you suggesting that shareholders are being deliberately fed inaccurate information and deadlines which have not a 'cat in hells chance' of being met ?

SUMMARY

The Directors of the Company are pleased to inform the shareholders of the Company and potential investors that the Phase II validation study of Fortacin™ in respect of the FDA approval process in the US was officially registered on 6 July 2018. Recruitment of subjects (100) for the study is expected to commence next month, with the study estimated to complete by October 2019.

On the assumption that the trial is sufficient to convince the FDA that the PEBEQ serves as an appropriate measure for support of a label claim, pivotal Phase III work could commence in the second half of 2019, with NDA submission possible in the second half of 2020, giving a PDUFA date in 2021. These dates are the most recent guidance received and update all previous estimates on the FDA process set out by the Company in its announcements, annual and interim reports and investor presentations.
Alquemie
Posts: 1,012
Opinion:No Opinion
Price:0.00
RE: One can hope
Fri 10:52
Unfortunately not. As a Class 5 imported drug never previously trialled in China, local clinical evaluation is mandatory.

The unknown is whether the NMPA will accept that the existing clinical study dossier is sufficient for IND registration and CTA acceptance for at least one Pk study and subsequent pivotal study, or whether an additional study(ies) are required for IND and CTA acceptance.

I'd expect any additional IND-enabling study to be modest, possibly only a repeat of the extended dosing and drug metabolite studies in healthy Chinese subjects.
Alquemie
Posts: 1,012
Opinion:No Opinion
Price:0.00
RE: US study delay
Fri 10:49
2021? Only if time travel is involved....

The validation study completion date is March 2020. COA review is open-ended, but assuming a quick turnaround, the pivotal study would not commence until start of 2021. Statistics dictate minimum recruitment of 200-300 couples (2:1 randomisation, one month baseline assessment, three months on treatment, one to three month follow-up) and benchmarking against the previous pivotal studies, let's say 30 months to dossier completion.

NDA submission Q3 2023, acceptance and PDUFA date before year end, earliest approval Q3/Q4 2024.
Alquemie
Posts: 1,012
Opinion:No Opinion
Price:0.00
RE: Piracy?
Fri 10:44
@MattD78, experience has taught me to be wary of "industry averages" with respect to approval/registration timelines, but I will volunteer qualified estimates.

The Latin American countries do not require local clinical trial data for registration, at least for products previously approved in the EU and US. Assuming no issues over dossier content, GMP manufacture (Brazil and Mexico may undertake site inspection), time from dossier acceptance to authorisation could be: Brazil (24 to 30 months); Mexico (12 to 18 months), and Argentina (12-18 months, possibly closer to 12 months).

Saudi Arabia- 12-18 months, possibly closer to 12 months.

Countries other than China which require local clinical trial data (unless previously included in a multinational study, or where ethnicity was sufficiently represented in registration studies) include Russia (mandatory Phase III); South Korea, and Taiwan (pharmacokinetic and other bridging studies).

Taiwan does accept data from other Asian study populations and registration might be possible off the back of Chinese study data (although that's several years away); South Korea requires ethnic population study data, study size on a case by case basis. I'd estimate 36 months for both from dossier submission with local bridging studies.

Russia has a glacial review process, and including the mandatory clinical study, you could be looking at 4-5 years.

Above estimates come with a strong health warning in that they assume smooth sailing, with no extensive questions from regulatory authorities or GMP certification issues. Dossier requirements are increasingly more similar than different between jurisdictions, but allowing for translation and pre-submission review, I'd add six months to each timeline from the date of local distributor/agent appointment.
bignose58
Posts: 2,021
Opinion:No Opinion
Price:0.00
RE: One can hope
Fri 09:35
I definitely hope so...........

Trouble is after all that's gone before, one just has to reign in and go with the most pessimistic possibility. Even the market seems to have taken that stance too....... LOL.

Anyway, I must admit I am more hopeful there will be one or two more license announcements before that since that's all that's left to do...... ;-)
Montezumarevenge
Posts: 10
Opinion:No Opinion
Price:0.00
One can hope
Fri 09:22
Perhaps just standard wording, but hopefully means there is a probability, however small, of a further trial not being needed.

Development Milestone Payments
• A payment of US$4,000,000 (or approximately HK$31,200,000) upon obtaining NMPA
approval to conduct a human clinical trial of a licensed product or written NMPA acceptance
as sufficient of provided data without need for conducting a further clinical trial, which, in
either case, is expected within 6 months of NMPA approval to submit the investigational new
drug (IND) application for human clinical trial of a licensed product at NMPA.
bignose58
Posts: 2,021
Opinion:No Opinion
Price:0.00
RE: US study delay
Fri 04:39
Apparently the FDA asked for a change of protocol so recruitment was moved to Dec. The overall delay is about 8 weeks so immaterial for the approval process. Still expect an NDA PDUFA date in 2021.
pxsmaaaad
Posts: 131
Opinion:No Opinion
Price:0.00
RE: Gap closed
Fri 02:23
Seems like your prediction is spot on today! Lol
bignose58
Posts: 2,021
Opinion:No Opinion
Price:0.00
RE: Piracy?
Thu 21:32
That is indeed true and I have written so earlier, however. That is purely speculation and we know where speculation has gotten us so far..... nowhere. What I wrote recently was based on what the company has factually stated and until we actually see something to change that, that's all we have got to go on.... no ?
Montezumarevenge
Posts: 10
Opinion:No Opinion
Price:0.00
RE: Piracy?
Thu 20:00
Not necessarily - the need for a further clinical study could be waived after the initial 6 month evaluation. Why sign a license now if sales 5 years away and subject to a successful clinical study?

In the meantime Recordati need to step up to the plate.
Montezumarevenge
Posts: 10
Opinion:No Opinion
Price:0.00
RE: US study delay
Thu 19:54
Unlike Merthyr Tydfil the Big Apple does not shut down for December.

Do not worry, recruitment will be a breeze given the product and the fact that it has already been approved by the EMA.
bignose58
Posts: 2,021
Opinion:No Opinion
Price:0.00
RE: Piracy?
Thu 14:30
Matt

Theyve bin in the pipeline for the last 4 years. 2 years ago they were at heads of terms (LOI). 2 years ago China wasn't even gg to be considered. Yet here we are with a China agreement n nothing else new.

The question is what's happened to all the others and what have they been working on apart from China for the last 2 years ? Doesn't quite make sense does it. Particularly since the Latin American licensee was near biting Jamie's arm off 2 years ago......lol
MattD78
Posts: 367
Opinion:No Opinion
Price:0.00
RE: Piracy?
Thu 13:27
Certainly hope there will be further agreements soon as they have been in the pipeline for some time so surely they should be fairly close.

Depending which agreements are next, does anyone know what the trial periods would be for the these potential regions (excluding US) ? That being Latin America as one example or any other region if anyone knows.
bignose58
Posts: 2,021
Opinion:No Opinion
Price:0.00
RE: Piracy?
Thu 12:10
No sales income for between 3 to 5 years, so currently as useful as a fart in a spacesuit ... :-)

Although initial licensing payments may negate the need for a cash call next year, however, it has been alluded that further agreements are on the horizon, we will just have to wait and see.
Yes2014
Posts: 60
Opinion:No Opinion
Price:0.00
Piracy?
Thu 11:48
So the market has decided that a licensing deal with the biggest country in the world is worth virtually nothing. Is this because they expect that the product will be bootlegged?
Escovido
Posts: 1,682
Opinion:No Opinion
Price:0.00
Gap closed
Thu 09:48
as predicted, then it bounced back up to almost level on the day. Onwards and upwards!
pxsmaaaad
Posts: 131
Opinion:No Opinion
Price:0.00
RE: Difficult to Explain
Thu 01:50
I am also surprised why it didn't take off despote an unexpected sweet deal.
Most likely, the sellers were those who bought at placing at 40c . May be they prevented a rise above 44 plus
Pending court case due in March may also be a worry for potential investors
Alquemie
Posts: 1,012
Opinion:No Opinion
Price:0.00
RE: US study delay
Wed 17:30
Thanks- didn't thing I'd imagined it. Not like JG to get something wrong...

In fairness, he may have assumed that the study being listed on the centre website indicated "recruitment". Protocol change is minor, so only consequence is delay, although December in New York State is not the best of times to begin a clinical study.




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