Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
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Just in case anyone is interested,there was a tweet yesterday from DLI referring to the launch of senoclock gold.the blurb refers to "designed to empower your workforce with personalised health and wellness insights", whatever that means. i 'm not on twitter so can't read it, but looks as though it is aimed at employers. doubt it is of any real significance in the overall scheme of things.
"Not dead in the water"... Never underestimate the power of self-delusion...
For those not hard of thinking-Take.A.Look.At.The.Data.
https://classic.clinicaltrials.gov/ct2/history/NCT03578783?V_29&embedded=true
No need to worry about "the patent"- actually two, both expired 2014 in the US. Even the few SPCs granted in Europe post-approval have long since expired. Exclusivity, not that it means anything, will be lost in two months' time.
Do try and keep up.
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.
Hello dougie,i certainly don't have any expertise in the technicalities of the fda approval process and the challlenges facing fortacin in the US. my" longshot" comment is based on nothing more than the continuing failure to announce SPA agreement,despite several optimistic statements suggesting it was close (my interpretation of their announcements).i completely agree that there has been no statement of a problem, so i may be pleasantly surprise by good news at some point,but i have been waiting hear about the progress for several months now and the failure to provide any detailed update in the recent results is now suggesting to me that there is a problem which they won't disclose.i do hope im wrong and, of course, this is just my personal inference drawn form the delay etc..as i say,let's hope im being unduly pessimistic.
Hi guys, not sure why thinking USA is such a long shot, yes there have been delays, but there has been nothing stated in announcements that there has been problems encountered that mean it will not keep progressing ? Maybe I am uneducated to the process and you guys know more about how it works. hopefully full steam ahead with China anyway!
Hello keith and bignose.still here.just not been a great deal to write about.i checked the news for DLI which i do most days,but nothing there today.yes should get china news of submission fairly soon.FDA is looking a very long shot now,but you never know. keeping fingers crossed as usual!
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.
Very quiet not wiiet. Fat fingers on an iPhone!!!.
It has been over 10 days since the last post. I’m hoping that Bignose and The Italian haven’t given up. Their posts over the last few years have kept me going and still clinging on to a modicum of hope. Ironically it took me forever to obtain a new share cert with the last name change for a few shares that I am unable to add to the RP shares I have with Ii. Now I have a share cert with Endurance; I’m wondering if it would be better to hold and anticipate a reversion to Endurance again!
Evening bignose. hope the move is going smoothly.
yes, perhaps i was being unduly negative, but it is all so frustrating .obviously i agree re US progress, although i think you will find they still the have same reference to a US deal as the last couple of times (page 21, last paragraph under the US commercialisation section), so that does just keep that hope alive.
anyway, news of china nda submission by end of september we hope.
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.
To paraphrase James Carville, "it's the Phase II results, stupid"...The only puzzlement is why request an SPA prior to EOP2- a desperate "keep it in play" gambit, or do they genuinely believe that communication to date is sufficient to give a full picture? Twenty months since initial data submission and five months since supposed SPA request submission with no response. Considering the nonsensical study outcomes, I'd think the strategy obvious.
Coming up for 10 years since EMA approval, sole revenue is from a single batch placed with wholesalers. I can confirm that another batch is available, although it will be interesting to see whether there's still an appetite among German (and perhaps Italian) wholesalers. No supply in Spain anticipated before November, no date for ex-Europe supply and, perhaps of more critical importance, no third-party supply agreements in place.
DLI continuing to defy the maxim that there's money to be made from woo-woo wellness...
Despite reading several times the convoluted(and dare i suggest deliberately obscure) description on pages 20 and 21 regarding the FDA application, i am none the wiser as to what has impeded the progress in reaching agreement on the SPA, which wax expected by end of q2 in the end of march results statement. i find it deeply disappointing that matters have not been clarified in any way. this issue is,imo,critical to the company's viability. to keep investors in the dark over this and to keep hiding behind vague and virtually meaningless assurances of positive progress and (feigned?) confidence, does a great disservice to those PIs who remain invested.
It seems clear from reviewing the latest statements,that there is no possibility of regent carrying on without some form of further financing. clearly no prospect of any US licensing agreement for some considerable time(if ever).china payment not going to happen till the earliest and of 2024.nothing of substance from DLI and so far as i can see virtually nothing from sales of fortacin in those few areas where they have been able to secure supply.looks like cash might last till feb or march of next year,but thereafter it looks pretty dire. can anyone suggest any reasons to be more optimistic?
Well not sure what to say.on first reading it seems pretty much a rehash of what was said last time.no clear information re spa just more of the same will re read,but basically feel we are no further forward.
Morning bignose. yes, agree that DVP's decline will be in large part down to the negative messages coming out of china. in the long term i expect the demand for copper will prove to be very strong and resilient,so hopefully just a temporary unwelcome blip,but who knows.
yes interims at last.agree the excuse book will probably be in full play.my main worry is that we will find(however they dress it up )that the US is now dead in the water. lets hope i'm wrong.
yes,im also back im FUM (modest holding now though) as I've been thinking about the potential of the totality of world markets and think they may actually become a takeover target at some point.
no doubt there will be more to say in a few hours time.
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'm bemused that, with the disastrous Phase II results being in the public domain for so many months, that there can still be any expectation of regulatory progress in the US. There is no validated co-primary endpoint, or even a credible path towards one. To repeat a previous (rhetorical) question, "what part of no statistical significance do you not understand"?
No amount of re-reviewing of exit interviews or EOP2 meeting advocacy was ever going to change this and guff about Phase III study submission and subsequent pursuit of an SPA should be called out for what it is. That said, I am looking forward to the excuses- a big boy mixed up the test and placebo drugs and ran away, or perhaps the Gibson family dog chewed the data?
And I wouldn't get all unnecessary over China. Delay already flagged in the Plethora Limited July filing, which may or may not be related to CMC and manufacturing issues (currently no Fortacin supply even in Germany, continuing absence in Italy and Spain flagged by corresponding medicines agencies), or perhaps the same interpretation of "positive data" was used as for the US Phase II?
So 4 trading days now till interims.it will have been 5 months since any comment on the SPA process. i don't see how they can avoid saying something in the interims. if it is dead in the water surely they will have to come clean.hoping that is not the case,but not feeling confident.
"Friend", eh. Bothwell- real, imaginary or did contact involve a Ouija board?
And if real, do you happen to be on the same medication?
Afternoon all. i hope you are wrong,bignose,re cash call but expect you are correct. only thing that could possibly prevent it would be an fda partner, but really can't see that happening now, with the continuing radio silence re SPA. looking like we may need to pin all our hopes on china.
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.
I’m all for being optimistic bothwell, but is there any reason we should value your friends opinion on the matter ? We all seem to be in the lurch here just hoping
I was in contact with my friend and he thinks USA and China will happen. He has sunk a lot of money into this over the years!
Too true,bignose. certainly expected to have heard before now.not a good feeling..i see we have the interims' date now.