Member Info for bignose58

And to add further salt to the wound. Come the 15th Nov and it will have been 10 years since PLE received marketing authorisation throughout the EU. Ill write that again. "10 years". What a complete and utter waste.

Hi Keith,

Of course I'm still here, but as The.Italian has written. There hasn't been anything to write about. I am a little disappointed that we have still not heard anything regarding the China submission which initially I put down to possible pre submission contact, however. I wouldn't expect it to go on for 5 weeks given they were supposed to have submitted by the end of Q3 which doesn't follow since they have usually been above the curve regarding timelines. That said, either RPGs experienced management have gotten involved which has caused the delay (nothing unusual with that) or it has indeed been submitted but Jamie is far too busy with his other ventures to keep the market updated (I don't think I'd be wrong in suggesting since he has delayed informing the market before).

I have given up hope of RPG obtaining the FDA approval since all they have done is lie and mislead on their abilities to keep to timelines (its has now been over a year since the 2nd set of answers were submitted to FDA's questions and 6 years since they advised the market we would have approval in 2017). It certainly cannot take this long for such a small amount of data 87 subjects and it would certainly wont lead to any license agreement given no one has even considered in stepping up to the plate so far, which would indicate they must surely feel there is no market for the product in the US. Call it sour grapes, but the delays and not wanting to commit speak for themselves.

What this all means of course is money running out by Jan / Feb next year and yet another cash call, but who is left to inject more money? Even the A team must surely not want to inject anymore money as it now has become a huge risk.

Jim needs to be strung up for allowing this all to happen and not consider sacking the CEO/BOD and replacing them with competent and experienced people, but then again, he has done this before with his hobby companies which have not come to much.

Based on the last update, the new manufacturer may have solved the impurities problem but they have yet to solve the supply issue given they can only supply Recordati 30k cans every 4 months, remember that the cost of a can is now approx 60% less than it was before, so 30k cans is utterly abysmal.

As we can do is wait for the Chinese to pull their fingers out, but that's only if there is a company and a product still in existence !!!

Will the company be forced to sell the product to Recordati or even another ?

I'm not even going to mention the DLI which is now a bigger white elephant than the last one.

Anyway, onwards and downwards.

Oh and although long-term PLE holders are down by about 80%, spare a thought for all the gullible RPG holders who had even less to start with after the PLE takeover.

Nuff said. :-)

Morning The.Italian, maybe.

So, Q3 has has come to the end and holders are no wiser….this week or next for the NMPA submission (throws hands in the air) ?

Well, that's interesting. It's currently 15:09, yet the only trade today which lifts the SP was at 15:42

15:42:55 10,000 0.870 8,700

So, was that a trade from last Friday.? Certainly points to manipulation going on to mess about with the SP.

Morning The.Italian,

Maybe you are correct, however. I’m sure small investors who don’t have much to begin with are more likely to be cautious, but of course it’s anyones guess.

NDA hopefully sooner rather than later, RPG aren't exactly forthcoming with any updates or news of any sort.

Probably the Evergrande issue causing the market in gen to sell out. Investors running scared in advance of the overall impact it will have.

Morning The.Italian et al..

I was wondering myself. Going from previous Chinese info, they have usually been in front of the curve by a few weeks. This time however, it seems a little different since there are now only 5 working days to go which is unusual. That said and although speculation on my part, they could already be in contact with the NMPA to ensure all the required data is submitted. The last thing they want is a drawn out question and answer time along the lines of the FDA process (its been over a year now and that's just for phase II ...WTF). So they may be working on getting it right which could delay the submission a week or two, if not more. Pure speculation on my part,, but surely some contact with the NMPA wouldn't go amiss ?

Certainly going on today. A buy of 10k lifts the price 13% followed 4 mins later with a 30k sell at the same price, then a 10k buy brings it back down again….

Its been posting since 2013. I don't think I'm too far wrong in suggesting that most have it on filter since it has its own agenda driven by sour grapes and NPD (which is fueled by providing a response).

Narcissistic personality disorder (NPD) is a mental health condition in which people have an unreasonably high sense of their own importance. They need and seek too much attention and want people to admire them.

Nuff said.

I don’t know about you, but I found it very laborious trying to read it’s posts, so much so, I gave up after about the 5th double line entry. What’s with the two line approach ?…… I wonder what’s wrong with just a summary, I’m sure many more would be interested in just a summary.

Of course the US is not dead in the water, but based on the constant deception on dates, one can only assume there is still a long way to go. They have yest to start phase iii and based on how long it’s taken for phase II, a long wait has to be expected and by the time they do eventually obtain approval, how is the all important patent going to look. Ie how much time will there be remaining ?

Anyway, as I wrote, all hopes must now be with China.

Keith, certainly not given up. Moved apartments so not much free time to post. Although I have decided any sign of a US deal is still far away, China now seems to be the place which will turn things around. The total incompetence in addressing the FDA approval process is laughable and could be considered as a bad soap, if it wasn’t for the fact it’s real.

Not much to write about, but expect the NMPA submission in the next few weeks, which, I’m sure could stimulate some buying and possibly an sp spike.

Of course that’s 32% of Haleon’s part, but surely still not to be sniffed at.

Whatever Pfizer loses on Viagra, they still get 32% of the new product, which. If it takes market share from all other alternatives, may end up not be much of a loss to them.

Morning The.Italian, just a quick squizz as I'm in the process of moving.

For me it reads as if its all chugging along, however. The usual fly in the ointment is the laborious FDA approval process which is taking an eternity. It is now a year since the first submission with queries was returned. Certainly beggars belief with such a small number of subjects and now there is no longer any ref to a us license agreement......

I am still hopeful of the China approval which should change things although, as you state, they will need more money injected before they can even consider starting phase iii.

Morning The.Italian.

I see DVP has declined nearly 30% in the last 6 to 7 weeks which I guess is due to Chinas recent financials

Interims tomorrow. Will be an interesting read with, I suspect, many excuses.

FUMs product appears to be selling like hot cakes. I recently bought back in as I felt it had gone as low as it could with sales figures expected soon.

I for one am anxious about the FDA since incompetence rules. One just has to reread all the announcements and emails received where lies have been openly made and miss information passed on to understand what a complete cokc-up the company has made regarding the approval process which leave me with the bad taste that they may have missed the boat.

The Chinese approval process, however, is going according to plan as the process has no connection with the monkeys running the company. I fully expect approval mid next year.

That said, I fully expect another cash call with further dilution as they will have no money, yet again, come the end of the year. A totally unnecessary requirement if they had gotten their act together several years back. What a complete disaster management have been. Led by a chairman who has absolutely no business sense in this area. A person who should have replaced the bod and ceo with experienced and competence people from the very beginning.

Morning The.Italian,

I’m afraid it’s going to be flip of the coin on FDA news. Something certainly doesn’t seem right. It really shouldn’t be taking this long. It’s not like the FDA has reams of data to go through. Just less than 90 subject data, yet 5 plus years to pass the phase II finish and its still not done, sumfings up

And still no update or obvious progress on the FDA submission which is still stuck on Sept 22. Another few weeks and it will be over a year since the results were first submitted. What a debacle it has been from the start.

https://classic.clinicaltrials.gov/ct2/show/NCT03578783

I notice the gov website for the phase 3 is now showing completed. it was only a month or two ago, last time I looked, that it wasn't showing phase III as fully "completed" but instead had some other dialogue there (cannot remember what was written but i know it wasn't just the one word "completed" as per now)

http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml

Seems progress is still being made. Maybe that's what caused the recent interest ?