Member Info for bignose58

Actually the wife sent me a txt recently telling me she was out eating chicken with a friend....unf, due to predictive txting, it came out as children..........Although I know the Chinese are known to eat many things (never take your pet dog into a restaurant) I certainly fell off my chair on reading that one.

The next day she wrote she was having a migraine, which confused me since shed never had one before apart from when I've requested sex, but that's another story. Turns out she was off having Mee Goreng (an Asian noodle dish...google it)..... LOL

And both those are true and really did happen, although they did occur more than a few more days between...... ;-)

Yeah.... I ate a couple of those recently.... very tasty roasted....

Ahhhh sorry, thought you wrote chickens........ LOL

Cannot help but add a little regarding the costs.

Construction costs can be horrendous if not kept track of hence why overruns in time and cost can easily occur. One only needs a few days delay which can ultimately have a huge impact.

Although the below is a little unrelated, its still construction and may help in understanding:
One of these baby's can cost 2mill plus if not more a day for North Sea use. The new one shown here currently being built in Singapore to replace the recently retired Hermod will be ready sometime this year.

One of the prongs on a 4 prong lift hook is taller than a man and the hook can weigh between 50 to 75 tonnes. Large Lifting ropes or grommets can have diameters up to 300mm if not more depending on use and rigging arrangements.

I think it makes one have a better appreciation of these things and the planning/logistics that go into them.

Hope some may find it of interest: https://hmc.heerema.com/fleet/sleipnir/

The.Italian, I think most possibly, although nothing has been mentioned, that as progress is made with the FDA, either or both the North American and South American region licensees my commit to something.

Never asked about India, as you state it is a Saturday and HK are all geared up like Singapore ready for the CNY. Year of the male chauvinist.. LOL

Note: The year of the pig represents luck, overall good fortune, wealth, honesty and general prosperity. Based on my hands on experience on just how superstitious Chinese are (considerably), I wouldn't be surprised if all this progress regarding Asian HK / Macau and China have not been orchestrated to coincide with this years pig.......stranger things have and do happen ;-)

Oink Oink.

Bothwell, that may be so, but with 3.6billion males for the ROW, I cannot help think that the ROW outstrips that of the USA on numbers alone, even if divided by 3 to account for price, that's still 8 times more than the states.

Maybe that's why they have been faffing around trying to pursue the FDA approval which in my mind, if they were really that serious and had started with the 20 dose cannister, we probably would have had FDA approval by now. Remember, China was never going to be considered cos it would take too long..It became a game player some time after June 2016 when I was told by the man himself it would not be pursued.. It now seems possible we may get Chinese approval before the FDA..... :-)

From the man at the top ;-)

The.Italian

Something else you may find interesting. Apparently there was an issue with the prior batch filling process which went out of spec and as such the batch couldn't be released (Note: The cans have to sit 14 days before being released). The issue has been dealt with and Recordati will receive their latest stock by the 9th Feb, so expect the launch sometime after that date.

Furthermore, Recordati are still highly committed to launching the product in the EU and CIS as agreed and the North and South America license agreements are linked to the FDA approval process, which was never made that clear in previous announcements. Only the US agreement was alluded to being linked and then vaguely.

Or you may not find it so.

Many years ago I had shares in ideal shopping direct (IDS). The company was bought out mid year 2011. Although that's not interesting in itself, this maybe. LSE still has a BB with the last post being at the end of June 2011 !!!. Now why would they keep a BB going for an nonexistant company when they seem to police everything else?

Anyway, as I wrote, interesting...or not ?

Delayed as I predicted. I wonder what the excuse is since it must be pretty simple task in an already launched country. I also now begin to wonder if Feb will be kept. Thats twice they have not launched according to their own stated schedules. How will these delays impact all future scheduled launches ?

So. If Recordati have indeed made a "relaunch". What does that exactly mean ? Since they cannot advertise, doesit Just mean supplying more cans to pharmacy's or are they setting up consumer awareness seminars etc ? Any ideas on how they are going about it as there doesn't appear to be any media coverage, but then, I don't live in the UK so don't get to see much. Anyone local who have read or heard anything regarding this ?

Warrior.
Since its sold on a prescription basis, obviously an online doc WD need to prescribe 2 or 3 cans, which I would think they may decline to do. Although it does depend on how frequently a sufferer states they need it. Or is this number aimed at the lifestyle brigade ???

Would that indicate that Recordati have now relaunched ?

The.Italian
Although 2 very different products and with different approaches, what interests me is how they are overcoming the stigma attached to PE. They appear to be reaching out in the states, but I wonder how their device will sell in the UK and other countries. Any help from competitors in overcoming this problem, Will be well received by us. ;-)

Since its quite quiet here, ill just post some information from IDP who have a mechanical device (Prolong) for achieving the same results as our product as they are in a similar period to us. The below is extracted from their final results last Sept......Just FYI:

Prolong, the world's only FDA-cleared medical device for premature ejaculation, was launched in the United States and Australia in May. The launch was supported by a highly creative marketing campaign, a first of its kind, ground-breaking sex-positive platform with the aim to normalise and de-stigmatise discussions around sexual health and wellbeing for men. This resulted in the Company selling 622 units during the two-month period (May-June). The Company is seeking CE Mark regulatory approval for Prolong and, once obtained, the device will be launched in the UK and Europe.

The marketing campaigns were scaled back from July owing to a number of Prolong units exhibiting battery switch issues. Consequently, the Company is in discussions with a large manufacturer to start production during the first half of the new FY which will also have the benefit of reducing the cost of each unit by more than 40% compared to the current model. This development ensures that the gross profit margins are increased considerably once marketing has restarted. The packaging of the unit is also being improved and the Company remains confident of a successful relaunch prior to Christmas.

As part of wider global re-launch, the company has completed Japanese FDA registration through its distributor and is commencing registration both in China and India (two of the largest markets globally) to take advantage of the reduced cost of goods in what is traditionally price sensitive markets.

The Company is in discussions with a number of distributors around the globe to launch the devices in their territories throughout the new financial year. Post-period end, although the marketing campaign has halted, sales are consistent through DTC and is expected to grow once the marketing campaigns are scaled up.

And from the recent trading statement (10th Jan):
The new inventory for our Life Science product, Prolong is now available and we will begin to promote the product in key geographical markets. The promotion costs have been fully budgeted for and will be flexed in response to revenues.

Note: I have adjusted the above txt removing ref to their other non related product and only include for Prolong since we are not interested in the hair helmet, unless there are a few balding ppl who want to try it, then pop over to the IDP board...... ;-)

Well that certainly would have been a lot of Tom, Dick n Harry’s.....lol

True

What intrigues me is the “team member” bit. Are they just any ol Tom, Dick n Harry that requests it ? I.e can someone from a company apply with the right verifiable qualifications who can police a bb ?

If anyone is interested and I cannot say that I have noticed LSE doing this before (seems genuine though as they are listed a s "Team Member" and include the LSE icon).

Over on the CTAG BB (CTAG is no longer listed so one needs to just type CTAG in the search box and push enter). LSE have posted a reason for removing a thread there. Interesting that no one from LSE has seemed fit to provide reasons at to why several threads were removed here.....maybe they couldn't think of a reason.......LOL

I wonder what a "Team Member" is and how does one become one ?

The.Italian

Knowing the way JG works, since its a closed period, no announcement will be made. If the launch has occurred, it will be announced in the end of year results as part of the usually included operational update. You can always email Recordati investor relations to get the latest update. They may even have a new launch schedule for the remaining E5.

Pdub

So including 2018 that's 4 x 1.5 = 6mill USD........ And about 4.5mill since PLE became a part of RPG.......... Think we all need to get jobs as CEOs.... :-)

MR

That info was from PLE in 2013/2014 which may be my misinterpretation ["including major pharmaceutical companies, for a launch of the product, with the initial focus being on the markets within the European Union, the United States (subject to regulatory approval)"]. Anyway. subsequently a clearer statement was made in the 2015 outlook (An announcement regarding a commercial partner for the US market is not expected to take place until the Company is further along the process of securing FDA approval).

with regard to the FDA approval process itself. Can anyone clarify to me what went wrong following the initial agreement with the FDA. What made the FDA change their agreed requirements surely it cannot be related to the switch from 20 to 6 to 12 and back to 20 dose can size ?

In January 2014, a successful guidance meeting took place with the FDA in the USA to establish a defined pathway to secure regulatory approval to commercialise PSD502™ as a prescribed treatment for premature ejaculation in the USA. The agreed pathway will require supplementary clinical trials to be carried out to facilitate the completion of a new dossier for approval.

In relation to the FDA approval process, a new clinical trial will commence in the latter half of 2015, which will allow the new clinical dossier to be submitted in early 2016. In accordance with the protocol prescribed by the Prescription Drug User Fee Act, the FDA will be required to respond to the dossier within a 10 month timescale which would facilitate a commercial launch in the USA in the first part of 2017.

Also, it was announced that: Another substantial barrier to entry for a generic is the time and cost of undertaking a Phase III study, which we estimate at being 3 years for completion of such study and at an estimated cost of US$12 million to US$18 million. are these cost still applicable and do they apply to us ?

Finally. anyone have any idea what happened to the US patent coverage which we were advised would run till March 2015. Was it extended ? Could it be extended ?

"There is US patent coverage that runs to March 2015 but, if FDA approval of PSD 502 is obtained, a patent term extension ("PTE") may be available.  PTEs provide an extra period of up to 5 years after the US patent would ordinarily expire, to compensate for time lost obtaining regulatory approval of the product". 

Appreciate any feed back on the above rather than contacting the man himself.