Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
Something's up today
I see, still good news as his buys more often than not do well. He must have hoovered up all the loose stock.
Twitter player big pockets taking a punt. Called AfzalValli
On Friday 4th Feb at around 15:50 a 173K buy followed by a 86K buy and then a few small buys after that. I tried to buy just before market close and could not buy any, not even £500 worth of shares.
Probably nothing and me reading too much into it, or has someone got wind of approval for BP101?
Agree ALGU - Certainly with EMA and FDA submissions the company will receive questions, from the regulatory authority, during the review process. I've never dealt with the Minzdrav but I'd be very surprised if there has been no communication since submitting a year a go.
The sentence they used in the RNS is interesting -- "While Ovoca cannot be definitive about timelines, management remains optimistic with regard to approval perspectives for Orenetide in Russia and is hopeful that the review process will be completed shortly. A further announcement in relation to the approval process will be released by the Company as and when appropriate". ...
I don't know how much we can read into "remain optimistic" but I see they have used "cautiously optimistic" in the past about the company's prospects.. . They also start the sentence with "While Ovoca cannot be definitive about timelines" - which is fair enough, but does that suggest more confidence "with regard to approval perspectives" ? I guess with the choice of words we can only assume that any correspondence to-date has not suggested a negative opinion at least?
That all said for those of us old enough to remember the game show 321, and trying to read into the clues, - I could never work out which ones related to the car, and which were dusty bin, so my interpretation may be way off.
31st Jan 2022 7:00 am RNS Board Changes and Update
... Operational updates
In addition to these Board changes, Ovoca Bio today announces the following updates:
· Seventy percent of patients have now been enrolled in the Phase II dose ranging study assessing Orenetide (BP-101) being conducted in Australia and New Zealand. While the COVID-19 pandemic has significantly impact clinical trial related activities globally and has affected our trial, the Company intends to complete recruitment of participants in H1 2022.
· The Marketing Authorization ("MA") application for orenetide is still under review by the Russian Ministry of Health (the "Minzdrav"). While Ovoca cannot be definitive about timelines, management remains optimistic with regard to approval perspectives for Orenetide in Russia and is hopeful that the review process will be completed shortly. A further announcement in relation to the approval process will be released by the Company as and when appropriate. ...
https://www.lse.co.uk/rns/OVB/board-changes-and-update-0gr8yy87jnzc2v0.html
31st Jan 2022 7:00 am RNS Board Changes and Update
Dublin, Ireland, 31 January 2022 - Ovoca Bio plc (LSE: OVB; ISE: OVXA) a biopharmaceutical company with a focus on women's health, is pleased to announce the appointment of Dr. Kristina Zakurdaeva, MD, PhD as an Independent Non-Executive Director effective immediately. Dr. Zakurdaeva succeeds Chris Wiltshire on the Board. Mr. Wiltshire has resigned from the Board and role of Chief Business Officer with immediate effect to pursue other business interests.
Dr. Zakurdaeva currently serves as CEO of New York-based Incuron (Buffalo, NY), a drug development company in the oncology sector. Before Incuron, she served as Chief Medical Officer at Gero (Singapore/Russia), a drug discovery company focused on aging and aging-related diseases, where she developed clinical strategy for the company's pipeline.
Prior to Incuron, Kristina worked as a Scientific Advisor at Bristol-Myers Squibb and later headed oncology and immunology R&D projects in the Biomed Cluster of the Skolkovo Foundation (Moscow) where she successfully launched the Cancer Center of Excellence. Dr. Zakurdaeva is a Founder and Chair of the Foundation Board for the Foundation for Cancer Research Support (Russia) and has authored numerous, recent, peer-reviewed publications and co-authored a scientific discovery in genetics. Kristina holds a medical doctor degree in internal medicine and hematology, as well as a PhD in genetics of acute leukemia.
Kirill Golovanov, Chief Executive & Interim Chairman of Ovoca Bio, commented: "We are extremely excited to appoint Kristina Zakurdaeva to our Board. Her appointment, following that of Anastasia Levashova, adds to the complementary skill sets and breadth of perspectives on the Board of Ovoca Bio. Dr. Zakurdaeva brings extensive expertise in biotech and drug development in the USA and globally. Her strong clinical and scientific background, as well as business development experience, will be invaluable in the next stages of Ovoca Bio's journey. On behalf of the Company, I would also like to thank Chris for his contribution to the Board and as Chief Business Officer." ...
https://www.lse.co.uk/rns/OVB/board-changes-and-update-0gr8yy87jnzc2v0.html
Good update today and sounds like things are on track. Hard to tell if the board have actually received any unofficial news on the application almost being signed off, but that's what it sounds like they're saying
Good to see some more chatter on this board. Very surprised this hasnt attracted a LOT more interest, especially consideng the huge potential if Russian MA is granted. Any good Australia trial news would of course be the icing on the cake!! Certainly well inside the news window, and this shoulf re-rate sharply if/when Russian Marketing Authorisation is annoumced. Been hammered on low volume, but that works both ways. Will be very tough to buy on news dropping!!
Website looks good. Would be nice to see the enclosed December 2020 presentation being updated…..perhaps the update is also just around the corner to capture Russia and Australia news when it lands.
The company has revamped its website (since i last looked) and looks very user friendly. https://ovocabio.com/
Could this be a pre-cursor to news and approval, and therefore selling the product?
The website style appears quite aimed at the consumer market
Well Morris, last time no concerns were raised about the drug's effectiveness or safety, which are the two key criteria:
2nd Oct 2020 7:00 am RNS Update re Russian Marketing Authorisation
" ... Ovoca has been informed that the Minzdrav has not granted the MA to BP-101 following the identification of certain issues relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the MA submission dossier. The Company notes that no issues were highlighted by the Minzdrav regarding the safety or efficacy of BP-101 in the acquired generalized form of HSDD, which has been established by clinical data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study completed in 2019, all as conducted in the Russian Federation. ..."
https://www.lse.co.uk/rns/OVB/update-re-russian-marketing-authorisation-oz9x0y7ggukj4jt.html
And the company had three months to address the other issues raised before resubmission.
OVB stated on 5th. January last year:
Kirill Golovanov, Chief Executive Officer of Ovoca Bio plc, said: "This is a positive development for Ovoca. We are confident that the questions raised by the Minzdrav, related to the CMC and labeling portions of the previous application rather than drug safety or efficacy, have been addressed in this new submission. ..."
https://www.lse.co.uk/rns/OVB/re-filing-of-marketing-authorisation-application-ik1nc4u9ygv9gv7.html
Also, this is a Russian company seeking approval for marketing in Russia, which should have smoothed communications.
What could possibly go wrong ?
OVB's initial marketing authorisation application with the Russian Ministry of Health, for BP-101, took 12 months & 20 days for a decision:
12th Sep 2019 7:00 am RNS Filing of Marketing Authorisation Application
2nd Oct 2020 7:00 am RNS Update re Russian Marketing Authorisation
The reapplication was submitted 12 months and 19 days ago, so on the basis of the previous timescale news should be imminent:
5th Jan 2021 7:00 am RNS Re-Filing of Marketing Authorisation Application
https://www.lse.co.uk/rns/OVB/re-filing-of-marketing-authorisation-application-ik1nc4u9ygv9gv7.html
*market cap
When, or rather IF, good news comes, i wonder what the SP will do. Based on past SP movements i would hope for +30p. The market can here is still little more than the cash in the bank.
Bring on a Christmas eve RNS...
someone sure likes this suddenly
It's happened before a few times!
Hmmmmm……Interestingly not showing up on the LSE risers board.
Me and my big gob - usual service has been resumed.
I've seen it move up and down 10% in a day recently on no news but an upwards move of 17% does look interesting - fingers crossed there is a positive announcement due tomorrow/tonight.
Price moving up now. News is due
Becoming a test of patience this one. But news could arrive any time this month.
Losing the will to live with this one
Losing the will to live with this one