Tim Watts, CFO at Shield Therapeutics #STX presenting at our Life Sciences Investor Briefing Watch Now
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Isn't Kim Eng now owned by Maybank ?
And I apologise on my first sentence. At less than 0.215, JG and the A team are at a slight loss....derrr. Honest gov I did get an A level in maffamatiks..... Lol
That should have been "disgustingly obscene salary" for more emphasis.... Lol.
20.5c.. Unbelievable! I notice Kim Eng very active in the market on the sell side with a stack of minor orders.
Nonetheless, VXR up 10.3% this morning - $100m of debt funding now secured from Trafigura. This adds HKD4m to our holding which is currently valued at AUD8.17m or 86% of the outstanding ATO bill. VXR rerating on the cards. All major boxes ticked with full production within the next 24 months. 10 year mine life. Strong margins and cash flow. Significant upside. Happy to hold.
Now below the placing price, so JG and the A team are in profit. They really should consider making a film ..... Lol.
And I'm sure it will edge lower since usually markets pay little attention to cash injections which are soon to be used up to pay such things as undeserved disgustingly high salaries and Legacy tax bills. It will all be based on what the market cap was before the shares hit the market. We are now at a price not seen by PLE shareholders since 6 or 7 years ago and that's now with 2 companies merged, a product which had a TO value of curca. 150mill USD, on sale for a year and 2 additional license agreements in place. WTF. Incompetent or what..... :-)
bignose apologies if my posts suggest i felt you were taking a shot at me .idid not think that and would certainly not wish to have given that impression.i entirely agree with you that the information we have been given by the bod is contradictory and implausible and as you suggest may well be designed to give an unrealistically optimistic view of fortacin's short term prospects to encourage interest whilst they try and reposition in some way in the cannabis area. they really do seem to be losing the plot time wise so i hope the possible china deal whatever it is brings some clarity to the situation and hopefully some new and competent and more transparent talent to the board.again apologies if anything i have written could be construed as taking issue with you.regards
I wasn't taking a shot at you. I was just agreeing with your statement. It seem to me they are now knowingly providing false information to shareholders old and new since it doesn't take anyone with half a brain to work out that phase II will take much longer than phase II. Are they deliberately making up dates to try and muster more interest and liquidity, especially with the ref to the CBD arena which they seem so desperate to enter.
I also remind you they stated they now had something more concrete following the Yooya fall-out, yet there was no mention of this earlier. It didn't just suddenly happen. So one is led to wonder if they are getting caught up in their own lies and have now lost all track of time ?
bignose just been having a further look at what has been said before about FDA timelines prompted by your comments.my time scale of 2023 is based on the time line given in the march 18th operations update which i felt was realistic.the suggestion that with a NDA submission in Q1 2022 they could actually get approval in 2022 is i think unrealistic and completely over optimistic hence i pushed my personal projection (guess really) back into 2023.even then there was scepticism from some quarters that it could take even longer if 2nd pivotal trial required so i could be being too optimistic but lets assume that things go as well as they can and give 2023 as a reasonable possibility.but then as you rightly say we have the most recent operations update which says it supersedes all previous guidance! what changed? things seem to be going more slowly that expected so like you i really cannot understand or accept the new time scale.have they simply got mixed up with dates? lost a couple of years here or there?who knows.if we can get approval by 2023 i shall be pleased.any earlier and i would be delighted.delight is not a sensation readily associated with regent so i am not holding my breathe. you rightly say the phase 111 trials need to be much bigger and if there is indeed a problem getting sufficient candidates with the necessary profile for the smaller current trial then it my push the phase 111 back even further.looks like a long road I'm afraid
afternoon bignose.not sure if you think i am giving too much credit to the possible cannabis scenario or the FDA application.probably both i suspect.as to the cannabis scenario its all just speculation of course ,particularly as we have no idea what is proposed or whether it will happen.as i have posted before the reference to an exciting and more beneficial china business (my description) may have been no more than a sop to investors disappointed at the yoyo yoyoings.and i agreed with you that it was suspiciously fortuitous and coincidental in its timings.that said i genuinely feel that there is opportunity here for a change of direction with regent ,or at least the prospect of giving it another dimension whilst fortacinf FDA application progresses.any strengthening of the board as part of this process would i imagine be very welcome particularly if it resulted in sidelining those board members whom you feel have let us down badly.i feel the need for o broadening of regents activities even more strongly because i entirely agree with your comments re FDA time scales.i don't think i have suggested that FDA approval if obtained is going to happen particularly quickly and indeed i think exactly the opposite for the reasons you and other posters have cited .the time scales suggested by gibson are simply not realistic.personally i would not expect approval until early 2023 as the process will undoubtedly take longer than expected imo due to what i think will be more exacting safety date requirements than with EMA.whilst i do think that interest may be generated among possible investors as the FDA process moves forward and that we may see some benefit from this as early as next year I'm just guessing and i think we have to assume that regent is not going to see any real growth from fortacin for some time(china factor is speculative but I'm not overly optimistic based on reactions to news so far) and this is why i think we desperately (i use the word advisedly) need a boost from another direction.time will tell but i do intend to stick things out as I'm sure you do in the hope that patience will be rewarded.best regards
You are giving them far too much credit........ Anyhoo, I was revisiting the operational update and I just cannot get my head round the statements:
"The Board is also pleased to report that the Phase II validation study of Fortacin™ in respect of the FDA approval process in the US is now estimated to complete by the end of 2019". And " On the assumption that the trial is sufficient to convince the FDA that the PEBEQ serves as an appropriate measure for support of a label claim, pivotal Phase III work could commence in Q1 of 2020, with NDA submission possible in the second half of 2020"
Correct me if I am wrong, but. Doesn't the phase III study require a lot more participants than the 100 used for phase II (yes indeed). Well, if its taken 12 months for the Phase II study to get to the point where they can convince......blah blah blah, surely for the phase III, where there will be a lot more participants, its surely pretty obvious that its going to take much more than the 10 or 11 months JG is alluding to before the NDA submission can be made (you notice he doesn't write late second half of 2020, but in the second half, which certainly can be considered as deliberately misleading, especially since they are meant to be the experts ?). Isnt it more likely to be at least 6 months to possibly a year longer than stated and that's only if we are lucky and all necessary participants come forward in haste ?
Of course, If I have missed something like maybe the 2014 unambiguous agreement with the FDA allows us to use the data from the EU, then I stand corrected........Ill eat my hat, but I am sure its not going to be that simple.
perhaps what i should have added at the end of my last post was that maybe, just maybe, the chickens do have heads after all.let us hope so!
apologies for harping on about the same theme but he above was on the FFWD lse site today.i don't profess to understand it entirely but it looks as though Cryptologic is moving out of the bitcoin mining operation and into something cannabis related.the relevance for regent is simply that there seems be ongoing links between various parties and companies.Nuuvera was acquired by Aphria,the canadian cannabis producer.lorne abony was founder and ceos of Nuuvera.antonio costanzo was head of international development at Nuuvera and is now ceo of EMMAC.if these two get involved in the new next big thing for regent,which is what i expect,can we expect some sort of involved deal with similar financial engineering.i am starting to get the feeling that there is some real substance developing amongst these inter-related businesses and that if regent can get involved in some way it could be transformational for the s/p.equally it could be a clever house of cards but the continuing news flow for Emmac doesn't give that impression and on friday Aphrias share price went up 40% on the canadian stock exchange after it surprised the market by turning an unexpected profit.this may all be completely irrelevant but its certainly very interesting to consider the possible implications for regent.what value would its HK listing have for someone wanting to get main market access for a cannabis producer in china?
bothwell thanks for posting.quick initial reaction as off out for day is that not keen on idea personally.dont like injections and would be concerned over long term effects or overuse.not sure what the analogous effect might be in this context to the facial paralysis observed in some "celebrities"through overuse but certainly wouldn't want to find out.if it helps to raise awareness of problem and profile of fortacin(marketing opportunity jamie!) then it may be helpful.
Heimdal, great to start the weekend with some positive chat. Not sure if you are being overalls optimistic but I’ll take it anyway. Anything positive at the moment is good.
morning heimdal.nice change to wake up to a positive toned post.interesting what you say re VXR.it is of course a substantial asset of regents and if it makes more sense to retain it for better times then i would be quite happy.always thought disposing of a holding of that size would be problematic anyway.rest assured i have no intention of selling up although i do understand those who have done so as its very frustrating here at times.i was disappointed when the yooya deal fell through but it may turn out for the best if the new idea is more likely to improve long term value (whatever it is).cheers
The Italian, WRT the ATO payment.. our current VXR holding is 13.55% with a value of AUD7.41m -
about 78% of the outstanding ATO payment. VXR in trading halt in relation to debt funding of the SS Project
in WA. Once funding resolved we should expect a sp increase. Full production within the next 24 months. Robust project.
News on CBD development in China and HK launch should not be far away. Keep the faith - sp will bounce.
exactly bignose which is why I'm hoping for at least one new board member. desperately need some new blood.hoping that "next big thing" if it ever materialises will involve new board appointee as per the Abony proposal re yoyo.no news re tax payment!oh well soon be another week.
Going by previous delays and management incompetence, which has clearly shown they couldn't manage to get themselves out of a browm paper bag, you may just be, but then again, we all may just be ..... Lol.
afternoon bignose.no i had not read the first part although i have now.i did see the reference in the comparison article to recent legislation etc but when i looked at the footnote (5) and cross referenced the Bill it said last action was a reference to a sub committee in march 2015 so clearly it didn't go anywhere unfortunately.to a layman there certainly seems as you suggest a lot of sense in having procedures for fast tracking approvals where a major and reputble jurisdiction has already given approval but the fact that there is not in relation to the usa and europe is presumably at least in part down to the apparent different rationales behind the EMA and FDA with the former as avehicle for rationalising a large number of potentially competing jurisdictions and the latter with the emphasis at least historically on consumer protection.looks like we are going to have to go down the full formal route to approve.i just hope i live long enough to see it out.lol
I assume you also read the second part (part 1) ?
What I found interesting is: "Efforts include recent legislation in the U.S. Congress to facilitate release in the United States of drugs that have already achieved European approval", which makes sense since more than 20,000 EU users have applied the drug in over a year without any reports of dicks falling off or the growing of extra limbs....
Total obfustication.....say no more !
All credit to Bignose for sharing, but the linked article dates from 2016, prior to the 21st Century Cures Act, and consequent changes in the FDA review process and a shift towards "patient-centric" drug development, with revision of the clinical outcomes assessment process being of obvious relevance.
The current FDA process should be viewed as a work in progress, with further major and minor revision anticipated as the 21st CCA is interpreted/reinterpreted and implemented over the next eight years.
All pharmaceuticals have, to a greater or lesser degree, safety concerns and Fortacin is of course no exception. Specific issues (drug interaction, age or disease-related hepatic impairment, potentially carcinogenic metabolite generation) and deficiencies in the safety data are clearly referenced in the EPAR.
The EMA took the reasonable and pragmatic view that outstanding concerns could be addressed through labeling and mandatory post-marketing studies. Recordati were able to wiggle out of the latter due to delays in marketing and absence of real life usage data.
The gamble is that the FDA (assuming "bother" is accepted in support of label claim) will also be pragmatic in consideration of a safety package comprising old and less than comprehensive data. Personal view is that, at the very least, it will require strong reassurance with respect to the metabolite questions and risk assessment around partner transfer. And let's not forget satisfaction of the crucial combination product rule.
back now and have spent a happy half hour reading comparison.interesting to note that statistically the FDA review process for drugs (as opposed to devices)is actually quicker overall than EMA.unfortunately in this context "quicker" is a very relative term and our particular holy grail is still some time off.that said as each month passes the time for FDA approval draws closer(apologies for stating the obvious) and as I've mentioned before when we get to 2020, 2022 will start to feel much closer.im afraid that to my cost i do have a passing acquaintance(no more) with the FDA process having been invested in motif bio which has recently had a very turbulent time. to me as a layman the outcome there certainly seems to bear out the FDAs concentration on the safety aspects of new drugs as a prime determinant of the approval process outcome which seems to have outweighed the putative beneficial effects of the antibiotic under review there.in the case of fortacin i would not expect there to be any safety concerns and regardless of the suggested difficulties of establishing "bothersomeness" as a recognisable concept of substance to support the application (my interpretation of what has been said before so apologies if not technically accurate) i would feel relatively confident of a successful outcome to the FDA process (EMA approval must on a simple level indicate this is likely) so hope fully its just (ha ha!) a question of time and money to get there.what may happen in the meantime is, of course, anyones guess.on a more prosaic note aussie tax due today. news awaited.
thank you bignose for that.i shall have to leave reading it for a bit as out for most of today but will read with interest later.cheers