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Profit...
Ring the Bell
All depends on prift margins and credit terms.. 30, 60, 90 days etc...
I would hope they can negotiate better terms with suppliers than they have to give away...this way the initial investment will simply be rolled over together with profits to finance growth for own sales but they will want to get real volumes on a licenced basis.. This will be where the big bucks will come from.
Great, thanks Matml, good to know it's all coverd off.
Ring the Bell,
The placing from March was specifically for ramping up production for this winter in the event the trail was successful. The money was not just to fund production for the trials. This has been reiterated many times by RM in interviews and is spelt out in the placement RNS.
"£4 million for Manufacture of SNG001 drug product and other supply chain considerations."
Where they will need extra funding/partnership is to ramp up production to 100,000 doses per month for 2021. This was stated in recent RNS.
Thanks for the reply Bella6532.
My question was more to do with manufacturing capacity. Typically, and especially if cash flow is an issue then stocks will be held for an 'as needed' basis. The need was previously only for the clinical trials, a limited number for Phase II. There will be a Phase III (my prediction) and thousands of doses will be required for this.
The MAP is now opening in many EU countries and the UK. The pressure for doses this year was really my concern. The UK can order a dose today, the Human Medicines Regulations 2012 allow for this, and that brings me onto my second question. If the final drug product is manufactured in the UK, then supply is immediate. So, UK will see usage first, if Clinigen are set up, then it could even happen today. Then likely France with requests through the nATU (here doctors will make a request to ANSM, who, if they approve will send to clinigen, who then approve (if appropriate) and then the drug is imported from it's manufacturing site (UK?). So, expect the first drug to hit France in late Oct. Germany (as per my earlier post) will get approval likely end Oct from BfArM, and then after individual cases are approved, and minimal importation requirements, expect to see first drug use in Germany in Nov. When cATU starts later in the year, expect it to really take off, similar case with EAMS.
As the winter will see increased demand for product and supply for the clinical trials will be protected, my question was really about whether there is capacity to deal with the expected demand in the next few months before the uptick in supply in 2021. BTW, don't worry about brexit and drug importation from/to the UK, it's not an issue now. Post Jan, I understand there has been an agreement for drug supplies to be protected.
RingThe Bell...the Results RNS has these three highlights:
· Synairgen launched a Managed Access Program with Clinigen, to provide SNG001 to hospitalised COVID-19 patients - see separate announcement issued today
· The Company is currently in discussions with regulatory agencies to establish the route to approval of SNG001 as a treatment for COVID-19
· The Company is also investing in supply chain activities to ensure that drug and aerosol delivery system availability can meet potential demand, pending approval
The first - done and dusted...check.
The second - route to approval...this suggests possibly getting Emergency Use first to speed up the route to hospitalised patients prior to getting full blown approval. This appears to be the case now based on France and perhaps authoritites are holding off on the full blown approvals due to Brexit talks not being finalised so they are uncertain as to how they should treat UK drugs going forward if third country regulatory rules are different to EU rules or perhaps new special rules for UK only.
The third does imply to me that meeting 'potential demand' refers to that produced through the Emergency Use route prior to getting full blown approval(s).
I could be wrong of course...but I think we are seeing the EU Route starting to unfold...
The latest RNS suggested that the company aims to have 100000 treatments produced per month in 2021, but does anyone know of the current manufacturing capacity, especially for the end of this year, now that the MAPs are opening in the countries?
Is the finished product made in the UK?