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Some fantastic info here UpDownWinLose, thanks for sharing and please pass on thanks to Timbo003.
Surely not a Trolley Bus !
Did you ask RM what happens if he’s hit by a bus?!
Cont:
Is it the intention to extend the MAP to outside of Europe?
Yes, every country has their own schemes. Some countries are easier to work with than others (according to Clinigen). If Clinigen want to talk to other KOLs in other countries then that is fine by us
If the MAP is extended to the USA, would you intend to do any direct to consumer advertising there?
We would be surprised if you were allowed to do that without a full approval
Have you completed all the scale up and validation work required for producing 100,000 treatments per month?
This work started back in April, we see it as low risk, so we are getting on with it and creating the reports, it is not completed, it all comes together at the end
If so, will the product from these batches be used for the initial MAP supplies?
Some of this material will be used for post approval supplies, MAP supplies will probably come from smaller scale batches. We will use what we can, we won’t be giving it away for free
What sort of regulatory approval will be required to commence the MAP in Europe, will it be done on a country by country basis in Europe, or will it be a centralised procedure?
Clinigen will manage the formal process when patients meet certain criteria.
Will you do any Interviews on the MAP announcement?
We won’t do any interviews on the MAPs or the interims. The next interviews are likely to be on feedback on Regulatory interactions, scale ups and possibly peer review publication, or whatever comes first.
Not sure if this has already been shared, but Timbo003 on the ADVFN guild had a phone call with Richard today and got a few questions answer. Below is a copy and paste:
My notes from the phone chat I had with RM earlier today, please note that it is not a verbatim account, but it is a probably a reasonable representation of what we discussed.
What are the most likely sources of funding for patients to access a course of SNG001, which based on comments in the most recent Finncap update is likely to be roughly the same cost as a course of Refib?
It could come from anywhere. This program is used when a Doctor is scratching their head on what to do, that’s when they contact Clinigen. We have had a lot of inbound request from physicians, but we haven’t been able to do anything about it. The Hospitals themselves often pay for the drugs from their own budgets, sometimes patients will pay themselves. Clinigen get a certain percentage of the sales. (Note: I also mentioned several time a £1000 – £2000 price in this part of the chat, Richard did not correct me on this)
KOLs around Europe will need to be made aware of the benefits of SNG001 in order for it to gain widespread usage in the MAP, the best way to do this is surely to get the proof of concept study published in a high impact Journal and follow up with a medical media blitz, can you give an update on progress on this front including target Journal and likely timing for publication?
Normally we would take a 6m to a year to get a peer review publication. This time it is not going to take that long, but it has only been a couple of months since we first broke cover with the preliminary data.
A lot of KOLs have heard of SNG001 and are already aware of the results and a lot of them have contacted us to have a relationship with the company. We cannot give an update on when it will be published, (I then suggested that the new clinical information in the RNS was a copy and paste from the draft manuscript, Richard replied that it was a good guess). A better way to answer the question was to confirm that the company was having a lot of chats with KOLs and regulators and disclosing information that we had not disclosed to investors and that didn’t seem right, so the clinical information in today’s RNS ensured that investors were bought up to speed on that new information. The other thing is that a lot of people seemed a bit confused as to how you can have a primary endpoint that can be analysed in different ways, well you can with a scale and you can interrogate it in different ways and all of those are the primary end points and it is nice to put it all in one place (i.e the RNS) and to also include the per protocol (PP) population, because people like that and they like it because the PP population took more drug and more drug equals quite a good effect ??