Member Info for bignose58

Otherwise, it just lists these. Item 1 being the phase III.

Just keep an eye out as item 1 could change to completed, any week now.

1 CTR20213293 In progress Recruitment
lidocaine prilocaine spray Primary premature ejaculation in adult males Phase III, multicenter, randomized, double-blind, placebo-controlled study of PSD502
2 CTR20213292 completed
lidocaine prilocaine spray Primary premature ejaculation in adult males PSD502 Safety, Tolerability and Pharmacokinetic Trials
3 CTR20213291 completed
lidocaine prilocaine spray Primary premature ejaculation in adult males PSD502 Safety, Tolerability and Pharmacokinetic Trials

There is a small icon to the right of the web page descript. (to the left of the blue star ""save bookmark" icon)

If you are using google, it should allow you to translate to English (mine does) ?

Don't forget to occasionally check the status of the Chinese trials....

http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml (search under PSD502)

Morning The.Italian,

Thanks for that. I’ll have a squizz.

I bet one the questions are.

1. Do you have any idea what you are doing yet ?
2. Why has it taken you so long when we gave you an unambiguous way forward at the beginning of 2014 ?

Its in a folder in Jamie's bottom drawer with a note "Not to be opened before Christmas or rights issue, whichever comes last".....lol

Morning The.Italian

Seems that way although they are trying to leave a false trail by making the transaction after hours so its outside the auto price matching system. No problem if you are just buying and selling to yourself....lol

Manipulation at its best.

I could be wrong but I wouldn’t be surprised if they want to keep the price at the rights issue sp so that Jim gets more shares and a higher %. Hence no further updates on EU/China/FDA.

The PDF itself was listed under "Changes since initial authorisation of medicine" which could also indicate approval.

The notes below on the first page state that the commission decision column is only for "procedures that affect the terms of the marketing authorisation", which I would thing a change in manufacturer has no impact, so it could be approved a stated in my first post.

I may have jumped the gun there since it lists an application number, but the date is listed as "Notification issued on", which could be an approval comment or just a comment on the application ???

dont know where that last with came from....lol

So It would appear approval may have been granted on the 15th Sept. (see the last entry which lists several changes including the new manufacturer).

https://www.ema.europa.eu/en/documents/procedural-steps-after/fortacin-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf

As suspected they are withholding information which surely has to be price sensitive since it now allows for product production for Europe and Asia with.

We will have to see what happens during the next 6 months.

The way it’s all been handled these last few years, has made it become more difficult to stay positive, especially with this last carp they are pulling.

Even though they have announced many times the US as the golden goose, they have certainly gone about it as if it’s not. They wasted 3 mill on the DBC. They’ve wasted 3 mill on the DLI and they have wasted nigh on 10mill on an undeserved salary. Just think, if all that cash had been put to proper use, we would have crossed the line a long time ago and certainly without the dilution.

I wouldn't get your hopes up too much as they would surely have to adjust the issue SP to account for the difference, although I am sure they wont.,,,, Could this possibly be a reason for delay..... errr nope....lol

Of course, they may just be day traders who think it will go up and have not read any of the recent news ???

Morning The.Italian

I see investors are still buying though!!! A recent buy of 1.75mill shares for example. I'm trying to understand why. Do they consider the current market cap to be half of what it should be and once the additional shares hit the market, they are counting on the FDA and China update news to negate the expected drop back to todays market cap ?

So as far as I can see, 2023 will be make or break.

It looks to me like there is only one chance left and that is China.

Given the total disastrous and incompetent handling of the FDA approval process. The main points being:
Announced March 2014 unambiguous FDA way forward
Announced 2017 would see FDA approval
Announced Jul 2018 Phase II recruitment started (whoops...no it hadn't)
Announced Recruitment to start by the end of Dec 2018
Mid 2019 Announced 15months trial period reduced to 12 months.
End of Dec 2019 announced increased by another 12 months since only 15 out of a 100 had been processed.
End of Dec 2020 announced trials completed.
Oct 2022 still no approval to commence phase III
There is def no way they will get the FDA approval across the line in 2023 or even 2024.

This only leaves any future income from China, which. If it doesn't happen, the company will either go bankrupt (I doubt JM will allow this to happen) or more likely Jim will take it private and pay shareholders next to nothing for their shares (just as he did for our DBC shares 3mill squid invested and he paid us only 10% of that value).

Certainly a lot of nail biting will be going on over the next 3 to 4 months as there will be no updates (apart from issuance of further delays with the rights issue paperwork). The only update which we may see within that time will be the usual profit warning.