The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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I have not seen any specific numbers but I believe the general consensus pre-covid was the Polx market was as big or bigger than Blue Earth Diagnostics.
Bracco paid $450m for BED and covid has clearly added additional market.
I assume Bracco will try and agree a takeover asap after FDA approval rather than wait 2 or 3 years for commercial success to increase the price even more. I believe management have the interests of all shareholders firmly in mind.
A link to an old article couldn't see an updated one.
https://www.google.com/amp/s/www.proactiveinvestors.co.uk/companies/amp/news/210960
Also before P3 approval were granted and before Bracco came on board - they will be able to open bigger markets for the company. But 500 million pound sales with a huge margin leaves a lot of profit and a huge future company just based on that 500 million before any other sales in USA and worldwide are considered.
Definitely a market for the product but does anyone know of any calculations of how big a market? Patient population and cost per scan?
Thanks Mavern.
"Coronavirus: Why surviving the virus may be just the beginning
By Chris Morris
BBC Reality Check
3 July 2020
... Even when that process is a success, it is only the beginning of a long process of physical and psychological recovery. And now the UK has moved past the peak of the virus, attention is turning to the huge challenge - both in the health service and in the community - of rehabilitating Covid-19 survivors. ...
"But because of Covid, and the number of people that it has affected, the need is pressing. It has become a national priority - to support people to get better." ...
Breathlessness
The most common physical challenge for recovering Covid-19 patients is shortness of breath - and that can apply to people who had moderate as well as severe symptoms of the disease.
"For patients that are coming out of hospital," says Sally Singh, "clearly they're breathless because they've had a respiratory disease. Their lungs are temporarily damaged, but they are also deconditioned because they've been lying in a hospital bed for so long that they've become pretty unfit."
It means that simple things like going up and down stairs can become extremely challenging, especially in elderly patients.
But breathlessness is an issue that goes well beyond survivors of intensive care. And a significant minority of people who've been infected with the coronavirus are still struggling to shake it off. ...
Challenges
Previous medical experience with pneumonia suggests it can take months, or in extreme cases years, for patients to get back to where they were before. With Covid-19, we are still early in the cycle of rehabilitation and recovery, and every patient is different.
"The honest answer is we don't yet know how long it will take," says Sally Singh. "People are researching that as we speak - monitoring chest x-rays, symptoms and the wellbeing of patients to help us identify what the best intervention to support these people may be."
The trouble is the provision of rehabilitation services across the country can be patchy, especially for people emerging from critical care. And the NHS is already dealing with a massive backlog of non-Covid cases that have been delayed.
"The huge challenge," says Krystyna Walton, "is going to be the increase in numbers."...
"And my suspicion," Krystyna Walton adds, "is that many patients may have not had their needs assessed properly." ...
It is important to emphasise those rehabilitation needs don't stop after the immediate recovery period. Many patients will suffer from scarring of the lungs - a permanent and often debilitating condition. ...
The NHS and individual hospitals are of course building rehabilitation into their Covid recovery plans, but this is a system that has been overlooked for years. Experts in the field hope, despite all the pressures, that Covid will provide a launch pad for change. ..."
https://www.bbc.co.uk/news/53193835
Many thanks for the update and link Hedgehog. The potential here is significant on many fronts. Aside of the Bracco takeover potential, the need for Polarean’s technology should be huge in the aftermath of Covid, by which time hopefully a fast tracked FDA approval has us to market providing a much sought after solution.
It's 6 months or so for a priority review ... but even faster than that if it's fast-tracked for the COVID-19 benefit.
"Priority review
From Wikipedia, the free encyclopedia
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. ..."
https://en.wikipedia.org/wiki/Priority_review
"Fast track (FDA)
From Wikipedia, the free encyclopedia
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days. ..."
https://en.wikipedia.org/wiki/Fast_track_(FDA)
I441,
POLX's expediated review issue doesn't seem to have been decided yet, and until it is POLX can't change the official timeline its given to the market.
A formal expediation request will probably be made when the FDA application is submitted, and I believe that the FDA will then give an answer on that within 45 days:
"PMA Review Process
... Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. ..."
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process
Interestingly the Blue Earth Diagnostics FDA approval only took 6 months under a priority review, and that was without the increased imperative that COVID-19 has created for POLX's technology.
Looking at FDA process....leaves me thinking it's hard to see why we would not get some sort of fast track/expedited/priority review etc. But I will continue to follow the official line that it will take the full 12 to 14 months so need to be thinking of Aug to Nov 2021 in worse case.
But also not unrealistic to imagine approval with 5 year exclusivity by Easter.
If we make application by end July with a request for priority or fast track review I guess the company will get informed if it's on that track? They presumably would hear that within 2 or 3 months of application... and would RNS the news.