The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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https://www.biospace.com/article/ovoca-bio-s-nasal-spray-for-low-female-libidos-in-mid-stage-trials/?s=115
Responsible for the interest ?
Especially if the OVB treatment for females can also be proven and marketed to benefit women in reaching Orgasm (this would be the holy grail…) as well as for increasing sexual desire, as was intimated in their RNS dated 24th June 2021.
FUM Male libido is valued 10x higher than this incredibly. this looks like a massive market disconnect
It was about this time last year the SP started to rise into the high teens. Let's see what happens in anticipation of the approval decision later this year
Thanks for that Comrieman.
They seemed confident that everything required for authorisation was with the health ministry to the point they had opened negotiations with a Russian manufacturer for supplying the Russian market once approved. The Co-vid lockdown in Oz could delay things there if it is a long drawn out affair was my interpretation.
Thanks for the feedback Comrieman.
Did you get any sense of levels of confidence and timescales for the Russian approval?
Previously the company has indicated October - December.
5th Jan 2021 7:00 am RNS Re-Filing of Marketing Authorisation Application
" ... Upon confirmation that the submission is complete, the Minzdrav will automatically commence a review process, which is expected to be a minimum of nine months duration. ..."
https://www.lse.co.uk/rns/OVB/re-filing-of-marketing-authorisation-application-ik1nc4u9ygv9gv7.html
24th Jun 2021 7:00 am RNS Annual Report and Notice of AGM
" ... In the market where BP-101's development for the treatment of HSDD is most advanced, Russia, our Marketing Authorization application is under review by the Russian Ministry of Health and we can expect a decision by the end of this calendar year. ..."
https://www.lse.co.uk/rns/OVB/annual-report-and-notice-of-agm-m7br0u8x2e22a1c.html
Also any general impressions?
Not much of interest, they are basically await the thumbs up in Russia for the spray and are in discussion with a producer there. They are building up to the 470 trial limit in Oz and NZ although co-vid lockdowns may interefere with adding new and monitoring existing patients.
I've registered for AGM and will report back after 3pm.
"Subject to international Covid-19 restrictions, the Ovoca Bio management team and scientists attend key industry events and conferences to meet with potential partners and investors.
To arrange a meeting with the team at any of the conferences listed below, please contact info@ovocabio.com
DATE EVENT LOCATION NOTES
June 10-11 & 14-18, 2021 BIO Digital Web-based North America Partnering Conference
October 2021 BIO Europe Web-based European Partnering Conference"
https://ovocabio.com/events/
Interesting to see that OVB is attending web-based partnering conferences for both Europe and North America.
This ties in with the company's stated global expansion plan:
24th Jun 2021 7:00 am RNS Annual Report and Notice of AGM
" ... Ovoca Bio is seeking to develop the drug for major global markets - in particular the United States and Europe, as well as obtain marketing approval in the Russian Federation. ..."
https://www.lse.co.uk/rns/OVB/annual-report-and-notice-of-agm-m7br0u8x2e22a1c.html
A reminder that OVB's AGM is tomorrow, which will hopefully provide some encouraging feedback:
24th Jun 2021 7:00 am RNS Annual Report and Notice of AGM
... Notice of Annual General Meeting
The Notice of Annual General Meeting ("AGM"), containing details of the resolutions to be proposed at the AGM, has also been published and will shortly be posted to shareholders. The Notice of AGM is also available on the Company's website at www.ovocabio.com . The AGM will be held at the registered office of the Company, 17 Pembroke Street Upper, Dublin 2, Ireland at 2.30pm on 29 July 2021.
AGM Procedures in light of Coronavirus (COVID-19)
Due to the continuation of the Irish Government's Covid-19 restrictions in relation to public gatherings and to prioritise the health and safety of our shareholders, employees and other stakeholders, the Board is requesting that shareholders do not physically attend the AGM and instead submit a proxy form in favour of the Chairman to ensure they can vote and be represented at the AGM without attending in person. Further information on how to appoint a proxy and the timelines by which proxies must be received are contained in the Notice of AGM.
It will be possible to listen to the proceedings of this year's AGM remotely using a teleconference facility provided by the Company. Shareholders will not be able to use this facility to vote, ask questions or table resolutions. Information on how to register for this teleconference facility is available on the Company's website at www.ovocabio.com/agm-registration .
All shareholders will be able to submit questions in advance of the AGM in writing by email to the Company Secretary at info@ovocabio.com to be received no later than 5.00pm on Tuesday, 27 July 2021. All correspondence should include sufficient information to identify the shareholders on the Register of Members. Questions submitted using these methods will be addressed by the Chairman at the AGM where possible.
As the situation is evolving and the Irish Government guidance may change, shareholders are encouraged to check the Company's website for any further updates regarding the AGM.
https://www.lse.co.uk/rns/OVB/annual-report-and-notice-of-agm-m7br0u8x2e22a1c.html
According to the company's website, the AGM is still on as scheduled:
https://ovocabio.com/agm-registration/
once rolled out more people will know about the sex nasal spray
MOSCOW, July 9. /TASS/. Russia will provide Internet across all of the country’s territory by 2030; over 1,000 base stations will be installed in remote settlements in 2021, Prime Minister Mikhail Mishustin said in a video address to participants at the Cyber Polygon international cybersecurity online training.
"We endeavor to ensure that the people can access the web all over Russia’s territory, including the most remote parts. We will provide this by 2030. We will install more than a thousand base stations as early as in this year to organize web access in every small settlement," the Prime Minister said.
Elimination of digital inequality remains a government priority, Mishustin noted. Free Internet access has become an important measure of the quality of life in the modern world, he said.
Bringing the Internet to the most remote corners of the country is particularly important because it means not merely information but also new options in terms of employment, the Prime Minister said. "We see already now the pool of vacancies for remote work is growing. Remote employment is gaining popularity," he noted.
Can women take Viagra? The Food and Drug Administration (FDA) has not approved Viagra for use in women. But your doctor can prescribe it for off-label use.
Last summer was a period of excellent OVB s.p. performance, starting with its final results, as investors anticipated Russian marketing approval, and the same should apply this time too.
Ultimately approval last year was temporarily knocked back, but only for minor procedural 'box-ticking' stuff.
Crucially, there were no concerns 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
So approval this time round looks like a formality, and it could be as early as October.
That should give an immediate big boost to the s.p., and should be followed by news on this:
"Discussions are progressing with a leading local candidate that can both manufacture and distribute BP-101."
Sales should then commence in Russia, the world's largest country, providing great cashflow to complement OVB's already excellent balance sheet.
And we also have the results of the Australia and New Zealand trials to look forward to, probably by the end of the year, a major step on the road to opening up other markets, including Europe and the US.
It's quite incredible that you can buy such a well-funded and proven biotech, with such massive potential, for a sub £10M. market cap.
A market cap. of £100s of millions looks very possible longer-term if the company delivers upon its potential.
Ovoca Bio plc BP-101 Presentation
https://ovocabio.com/results-reports-presentations/
OVOCA BIO JUNE 2021
... Ovoca’s approach - BP-101
• Novel synthetic peptide conveniently
administered through a nasal spray.
• Validated in Russian Phase II and Phase
III studies
– Demonstrated statistically significant and
clinically meaningful improvement in a
number of key efficacy outcomes in
HSDD.
• Clinically significant increase in female
sexual desire and reduces symptoms of
distress associated with HSDD ...
https://ovocabio.com/app/uploads/2021/06/201215_Ovoca-Bio-Corporate-Presentation-CSC_-updated-20210614.pdf
Interesting to see this part too: "To this end, the Company will partner with an established pharmaceutical company in Russia best able to commercialize BP-101 as quickly as possible after approval. Discussions are progressing with a leading local candidate that can both manufacture and distribute BP-101"
ORGASMS :
Hope the subject gets folks coming to read the post….lol.
Seriously though the RNS here today has important details about the potential for extending Ovoca’s female sexual desire treatment into also benefitting for achieving female Orgasm.
Crikey if this additional usage benefit can be medically proven and ultimately marketed then the value of this product which was already potentially excellent has just shot up by several orders of magnitude based on the level of envisaged patient demand.
Happy to be holding at this silly low mcap for what could ultimately play out on the future share price. Excellent risk/reward here IMO.
Has to be same person who bought this morning who sold again before the close, some mental traders out there!
do you use Rhohypnol by any chance?
This will be a big seller with men.
While their girlfriends are sleeping, it'll be really easy to just give a little spray up their nose...
MM's offering 10.67p and nothing to buy for a good while, stuck a small limit buy in at 11p but CFEQ not playing, will see if I get them in the auction for 10k as time to start using up the ISA allowance.
It’s even more crazy when you research and see that on the male market side there are various competitive treatments available versus the FUM offering, whilst for the female market if OVB can get their offering to market then theres will be an offering that is head and shoulders above the few other mediocre treatments that are currently available. Just need to have patience here.........