Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
Hang on, hang on! Can I politely suggest/request you don't tell anyone over Christmas! Some of us have been waiting for this for a long time and might quite fancy a top-up on Wednesday before the herd arrives. Feel free to tell the world from Thursday the 29th on though! ;-)
No doubt about it, it's genuinely approved. I've started from the FDA home page and accessed the same document via the 'This Week's Drug Approvals' link. We're over the line guys!
Congratulations and well done for holding strong everyone and well done to the team at Polarean. Hopefully we will now be handsomely rewarded for our faith and patience. Just sit back, strap in and enjoy the ride from here.
Who needs Santa Clause when the FDA are handing out gifts like this? Merry Christmas everyone.
Interestingly, I've just noticed that Okyo Pharma has received FDA clearance for one of its products. Was reported by the company by way of RNS at 07:00hrs on the 22 December. This would suggest that they received notification from the FDA sometime after 18:30hrs on 21 December.
The last three RNS releases relating to the NDA were actually released prior to UK market open. In the case of the last one, this was confirming the news that the FDA had granted the 30 day extension. As the company has to release this information as soon as possible in order to avoid a disorderly market, this would suggest that the FDA had notified the company of its decision sometime after 18:30hrs (the latest a RNS can be released in the UK) on the 29th September and before 07:00hrs on the 30th September.
Truth is, news could come at any time between 07:00hrs and 18:30hrs.
Good point and you're dead right there BigBlindBandy, the irony of the situation is crazy really.
I know we could, in theory, be made to wait until the 30th for a decision. I find it highly unlikely though. My bet is we hear something this week. I'll be up and watching every morning at 07:00hrs sharp until news arrives now, ready to react if the right opportunity arises. Good luck all.
The thing is, the volume is so low at the moment, the share price hardly moves. I guess this is because everyone has now taken their positions, patiently waiting for the FDA decision before making any significant adjustments to their holding. I'm certainly in this position and I can't imagine I'm the only one, so I suspect many other investors are too.
Just to give an illustration, whatever the decision (be it approval or another CRL), I am potentially a buyer of more shares. I have cash, sat waiting, for this potential opportunity. It is unlikely I'll be a seller though, as I believe the product will gain approval, at some point. So, why don't I buy more shares now if I'm so confident of a good result eventually? Well, because it's all about potential risk/reward. I currently have 27,500 shares and would be interested in increasing this holding to somewhere in the region of 55,000. The thing is, my average is lower than the prevailing share price. If I topped up now, I'd be increasing risk as I'd be increasing my average buy in price and doubling the amount of capital I've tied up for an uncertain period, before receiving potential rewards. However, if we gain approval this month, I might then be happy to add to my holding at a higher price (perhaps anywhere up to £1), as I would be more confident of near term rewards. If we get another CRL and the share price tanks to say 35p, I might also be happy to load up on the cheap and in doing so would be willing to accept that I might have to wait another year or more for the next FDA review and suffer a potential cash raise in the meantime. Like I've already said, if i'm thinking like this, I imagine many others will be too. If I'm right, that can only mean one thing. Whatever the decision from the FDA, the volume on that day will be huge compared to what we've all become used to.
You're welcome BigBlindBandy. That's the whole purpose of these boards after all, to share info/research. It's impossible to know or research every detail pertaining to every company you're invested in, all by yourself.
I would just point out that it appears (in my opinion) highly encouraging that the FDA chose to grant an extension to the NDA review period in this instance. They can, as I've said, choose to do this once per review cycle, but certainly don't have to by any means. The fact that they chose to do so, is a strong indication (in my opinion) that they had reasonable belief that they could approve the NDA, given a little more time to complete the review. If they thought there was no chance that they'd be able to approve the NDA with a little more time, they'd simply have rejected it or issued a CRL, as they did last year.
BigBlandBandy - There won't be another extension. The FDA can only grant one extension per review period. In the unfortunate (and I hope unlikely) event that we don't get approval before the end of this month, a fresh NDA will be required. That'll take us roughly another year down the road by the time the application is prepared and resubmitted and the six month review period has taken place. Keeping everything crossed!
newyorksaint - I don't quite know how to break this to you, but Saietta won't be making any engines, absolutely none! They make motors ;-)
jam2 - 'in coming year' is soon. That article was published in February 2022, not September as you might have assumed. Don't forget that the Yanks like to write the date a*se about face, unlike us!
just gone through for someone at 10:27. Not punt money. Demonstrates that people are still quietly building significant positions.
To my knowledge, we've only had one CRL so far.
Volume was pretty average again today, as it had been on Wednesday and Thursday, following the unusually high volume we saw on Tuesday. Most notable thing today were a few chunkier buys going through late afternoon. Possibly Yanks, or given the fact that news could land at any time over the next couple of weeks, possibly the Friday 'I wouldn't want to be out of this over the weekend' brigade.
Think you might be right AndrewUK. I think the market makers are starting to struggle for stock to satisfy buy orders. That false drop we had earlier was probably engineered to liberate a few shares. This theory is supported by the volume we have seen so far today, which is well above average.
For those that are interested, I can say with 100% certainty that JW doesn't hold POLX stock anymore. He specifically confirmed this in his 'Stocks to Follow' podcast with Paul Hill last week on V.O.X. Said he couldn't stomach the binary outcome risk. This is of slight concern, given that he has a regular chat with VA, who we know has direct contact with the company. VA hasn't mentioned the company on any of his V.O.X. interviews recently either. I find it difficult to believe that JW and VA haven't discussed the company privately, following the meeting VA said he was having with the company a couple of months ago.
I take comfort in the fact that we know of much bigger and better educated fish that continue to hold. We know this, as they would have to declare if they had sold anything, due to the size of their positions. I, therefore, will continue to hold.
So what are you saying TimberTrader, that Sam Garrett hasn't got any balls? That doesn't sound like it bodes particularly well for ***** Gold's prospects then!
On Vox Markets now!
BigBlindBandy - What is Justin Bieber's involvement in POLX? I hope none!
For anyone who is not aware and is not such a big fan as BigBlindBandy, a 'Belieber' is a fan/devotee/believer in Justin Bieber. This is according to many sources, including Collins Dictionary. Who knew!
Waltkts - Whatever happens now, shareholders are going to get wiped out I'm afraid. They come last in terms of priority in the list of creditors, so there will be nothing left for them, even if a buyer is found.
tomorrowtoday - How do you know that Vadim hasn't sold any of his remaining shares since his meeting with Polarean? Has he stated this somewhere that I have missed? If not, it is a bit misleading of you to state this on a public forum.
In terms of his holdings, the only thing I can recall him stating publicly is that he dumped a large chunk of his holding on the bounce that followed the initial CRL crash. He certainly did state that he had retained some of his shares though.
For the record, I have continued to add to my holding since the CRL and have a fairly significant position. I remain hopeful of a good outcome here. I would also expect that we'll hear something from the FDA before Christmas. I can't see that they'll want this on their desk to deal with on the 30th, as they'd probably rather be at home with family.