Member Info for bignose58

He did "BRUSH", but that too got swept away.....LOL

You can thank POM for the find. I'm just a happy conduit for the info.... ;-)

Dougie.

I would think the last few trading days volumes were indicative of some internal knowledge with some prepared to take the risk, which isn't to say the rest of the market know about it or want the risk. It will be interesting to see what reaction there is to an announcement., however. Given the lackluster volumes on the China and Taiwan announcements and the knowledge that EU sales were a disaster combined with the company continually reneging on dates may make investors understandably cautious to the risk particularly at this moment in time. Hopefully I am wrong, but historic incompetence could be an influence.

https://hbw.pharmaintelligence.informa.com/RS150284/EMA-Approves-EUWide-RxtoOTC-Switch-Of-Fortacin

I was thinking more along the lines of how stringent the FDA phase III requirements would need to be. I wondered if there was any possibility of a relaxation on the FDA part. Just toying with the idea.

Of course it may also influence a licensee coming forward sooner and signing that invaluable piece of paper given its now OTC approved. Many scenario possibilities. We will just have to see how it plays out, but it must surely have a +ve affect.

I wonder if the recent FDA delay is linked to this very OTC approval. Is it just a pure coincidence that when phase II is meant to finish and Phase II starts, Recordati receives the EU OTC approval ? Dr Mike, although involved with the FDA approval process, is also helping and advising Recordati on the EU.

I wonder if this will have any +ve impact on the FDA and China approvals or anywhere else for that matter ?

Surely it cannot be ignored that it’s now OTC approved (or soon will be) for Europe. :-)

The.Italian,

Obviously a revenue stream is needed, even if just to show II's that the company is worth investing in, however. Given that the new sales push will not happen till Jan 2021 and it would take at least a year to see any influx of money (remember we only get 15% of sales), they really do need to get the China money and a US license in place (with added upfront payment) for the company to continue given its yearly ...what is it, 4mill USD expenses ?

Its currently all touch n go if another placing is needed for the short term since they have no money and Jim will only lend so much. That said, as long as you hold, any income may be used to buy back the placing shares at a later date (just my thoughts). I am actually hoping for a good rise before JG's shares his the shop floor so I can sell some and buy back in after the loan dilution. It would be even better if, and I am only dreaming here, a US licensee buys the license for the states at a huge amount (or a lesser amount if they own a substantial number of shares...who knows if it isn't a licensee who has secretly been buying?) before JG's shares hit so we can all sell out at a huge gain, otherwise. If it happens after his shares are included, we all suffer with some dilution........ pure fantasy on my part as I am sure he will stitch us up for his own begotten gains.... ;-)

Still a Long way to go b4 most are back just to a level pegging. What will make this rise is any positive US news....like the long lost license agreement. :-O

The.Italian,

Thanks for the update. I'm pretty sure it isn't considered sensitive since JG wouldn't have provided an update otherwise. At least he wasn't Monkeying around when he responded to you.....lol. This probably explains the last couple of days volume. it was already known. More leaks than the titanic....... ;-)

Interestingly a sudden surge in volume today (after my post). Is this maybe an indication of a positive CHMP meeting (or in JG's case CHIMP meeting) that may have been held yesterday ???

I guess we will possibly find out later today by way of a possible announcement?

The.Italian. Seems it is being followed.....
https://hbw.pharmaintelligence.informa.com/RS150265/EUWide-Switch-Of-Premature-Ejaculation-Drug-A-Real-Prospect

Looks like Recordati are pretty positive regarding getting the approval if they are mentioning a Jan 2021 OTC launch.

As usual, buying has dropped off a cliff and now the slow decline with 10k sell here and 10k sell there....lol.

Hopefully news soon on the FDA, China and EU approval processes as we head towards August (need the China progress to pay unreasonable salaries...we must be running on air at the moment given the extra money required to expand the phase II testing). And we still have the mid year profit warning yet to come.

The.Italian. No point in running away from things as it would just be worse. And that applies to all things in life.

But anyway. My post was as a result of a discussion with JG (POM) and Dr M (me). Apparently they have several more laboratories/test centres on stream and are confident they will achieve the dates. But one has to bear in mind historical events etc etc so dont go out in the street a hollerin' just yet. And they do state its dependent on the C-19 which is an easy way out if it doesnt go that way.

We are all more than capable of sending an email requesting clarifications, all that is needed is for some of us to grow a pair and do it. nuff said..... ;-)

Certainly looks like they tried to get it up to that figure with the last 20k share buy 12 secs before the closing bell.... 8-O

Interesting to see how Friday pans out. Certainly doesn't appear to be the usual P&D and certainly no sign of Heimdal to help it on its way, which could be a good sign....lol

Actually for the last week it has been edging up, although I feel its being held back. There was even a 1.4mill share trade which didn't spike the sp. It reached 0.11 at some time which is the highest in the recent sessions.

Anyway, long may it continue.

The.Italian, I’m sure they wouldn’t commence phase III without knowing it was ok (imagine the consequences with the FDA if it was not). Maybe the FDA have already agreed its ok to commence ?

Seems they are pretty confident in recruiting the numbers by the said date. Could this be change our fortunes ? Certainly a week of increased volume suggests some local investors believe so.

The.Italian

Apparently, JG believes that if patients can be "magically" recruited by August 1st, the P2 study will be completed by the end of Sept and in the meantime they will take a "risk" and crack on with P3 prior to the P2 readouts. (they must be pretty confident of readout results). Also to note. Dr Mike was very positive about multiples in SP last time we had contact several weeks ago, which he has never been so positive about before.

Given that it was also announced that the Group’s strategy remains to continue negotiations with potential commercial strategic partners for the US market while we undertake the clinical work with the aim of securing a partner "just ahead of", could well indicate a licensee is waiting with pen in hand ???

However, as you state, there is a fat chance of that happening if they only managed 30 in 12 months and are expecting another 44 in only 3 !!!

One can only live in hope that they are finally running out of lies....... LOL