FDA meetings are most effective when they are focused on specific scientific or regulatory issues, such as clinical trial design, pharmacology studies, toxicology studies, acceptability of novel formulations, dosing limitations, data requirements for an IND application, etc.
https://www.vennlifesciences.com/articles-and-research/dont-be-afraid-of-the-fda/?fbclid=IwAR0s2FFwI8il4oEACs18JtD-ZD6OVjSYNQvjPXbZ5hCBeIBjcuxP8B9IJVk
Open Orphan
Open Orphan (AIM:ORPH), a contract research organization (CRO), for the testing of vaccines and antivirals, made waves this October with the award of a contract with the UK Government to conduct the world’s first Covid-19 ‘challenge study’.
The study, to be conducted by the company’s hVIVO subsidiary, will see, to discover the minimum amount of the virus it takes to develop Covid-19, and thereby help calibrate the future development of the vaccine. The first stage of this project will explore the feasibility of exposing healthy volunteers to the virus: if the research is approved by regulators it will begin early next year with results expected by May. The contract, which has already commenced, could be worth some £10m to hVIVO depending upon the final number of volunteers included in the characterisation study. hVIVO also offers a full range of COVID-19 tests through its COVID Clear programme.
The contract offers the prospect of a healthy return on Open Orphan’s investment in hVIVO, which it acquired for £13m in equity in January. The company’s interim results for the six months ended 30 June 2020 stated a cash balance of £14.7m following two successful placings in January and May. An EBITDA loss of £4.1m for H1 2020 was recorded, but the company is targeting near-term profitability in light of its strong pipeline of contracted work. It should be noted Open Orphan has another major subsidiary, Venn Life Sciences, offering drug development consultancy, clinical trial design and execution. Venn’s capabilities include CMC, Non-Clinical, Clinical Development and Regulatory Affairs.
Unsurprisingly Open Orphan’s share price has gathered spectacular momentum this year, rising from less than 5p in January to nearly 25p today. Continued uncertainty regarding the UK’s emergence from the pandemic means Open Orphan’s strong run may continue for some time yet.
Does anyone want to email open orphan investor relations?
I keep reminding myself that we have news inbound any day now and the company is a good one with a great team.
Its painful to be down 40k now but I made my decision. This will turn soon.
I noticed a gov doc on telegram yesterday but no access to my phone as i am in work. Does anyone here have the link? I will try and put it up when i get a chance.
Something to focus chat?
https://www.gov.uk/government/news/64-million-funding-to-back-uk-wide-plan-to-strengthen-clinical-research-delivery
Interview with Proactive
https://www.youtube.com/watch?v=4kC8jLh1ktY
Just thinking about SP. With the way I think this is unwind, I would think Disease in Motion will be last spun off as its the most valuable.
If at the end of the day, the SP is at 40p and I have all my current shares as well as shares in 4 other cos, spun off from orph and get my cash dividend at xmas, then I will say well done for sticking with the hold and dont sell sell strategy.
Roll on 1st spin off is right. I am just stuck in work watching. I find it educational watching whats happening with the way people react to evolving orph. Short term traders vs LTH.
My position? As I mentioned ages ago :............. Hold and Never sell.......... Up near 500% so all good.
Is this a spin off tree shake?
The COVID vaccine pioneer behind southeast Asia’s first mRNA shot
https://www.nature.com/articles/d41586-021-01426-9
??
Jumped over 1000%
I got some American followers on Twitter
$Orph is US ticker for Orhazyme
blue from 9:30.......... Nice
He did mention that we would be pleasantly surprised.
3 weeks until 1st July.
I think or should I say hope ;-) for some news.
For whats ahead, I would say this is a good price to buy at. I am all in so I can not buy anymore. GLLTH
G7 international health ministers will discuss collaboration on global health issues including four key priorities.
https://twitter.com/DHSCgovuk/status/1399274450827190273?s=20