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Should have said, I have not seen the SPRINTER protocol so can’t say with any certainty
Mike, it depends on exactly what the trial protocol says will happen with the data and the DMC. It won’t be to do with one country “finishing” their allocation, allocations can be changed by minor amendments of protocol/ethics. It is more likely the DMC will have a pre-determined peek at the data to look for futility or a strong enough result to decide efficacy and safety and stop the study at a planned number of recruits. All IMO
Just a question on the phase 111 trial. Say for instance the English arm of the trial was completed well before other countries (India) had even started. Then would those particular set of results be analysed separately as soon as they were finished, or do they have to wait until the full 610 people have completed the trial. I don’t mean actually announcing the English results before just if they would be looked at.
probitatis - yes we would be missing it.
Although what is the likelihood that we won’t be conducting a trial in India if they take too long. Of course we don’t know how recruitment is going in other countries and whether we’ll meet the date ex India. Suppose we could meet the estimated primary completion date from other countries’ recruitment which is more important from a drug approval point of view; having part of the trial done in India to collect a more diverse data set or get the trial fully recruited asap?
Doc - I think it’s anyone’s guess really as none of us has detailed knowledge of how it works in India i.e. do they have to wait to get approval from all trial sites before they can start or can they start as and when a site approves it. So it’s better to just go with 04 Jun.
Apologies I missed this bit of the approval process. Didn’t expect another level of approvals after the Regulator.
This was the SEC recommending approval to the final decision making body. They seem to be doing all the donkey work ensuring the application is thoroughly scrutinised.
Looks like the decision was made on COVID-19 SEC meeting 23.03.2021 & 24.03.2021
CT/14/21 Online submission (23828)
SNG001
M/s Paraxel
In light of earlier recommendation dated 11.02.2021, the firm presented their justification for phase III clinical trial before the committee.
After detailed deliberation, the committee recommended for grant of permission to conduct the study.
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/COVID%20Recommendation_23.03.2021.pdf
Well done picking this up WD. Sadly it is a June start there. "04/06/2021". I initially hoped it was the American system and read as 6th April but it is not as the first global case recruited is listed as "12/01/2021". Actually 13th Jan from memory. And I think this will not now change as it seems to be on this official Indian gov site. Each ethics committee will have been asked to consider the same paperwork and it will include these dates.
I suspect what happened here is that we listed many possible countries so as not to miss having location(s) with enough cases. It did not look fruitful to focus on India initially - low cases per head of population. So Parexel didn't focus there first. Given the changes in incidence they have pushed more for a start date for India and it has turned out to be very slow getting going. Remember this trial still represents a quick roll out of a multinational RCT believe it or not. Comparatively breakneck speed for a novel "investigational medical product". Though I do admit it now looks to be drifting from RMs initial plan for timings.
Fears of India variant found in the UK. Source. HuffPost. 2 hours ago.
I’m searching the individual hospitals that show approval for signs of recruitment but no luck so far
It just takes one country to lead the way, once we have one the rest will crack.
RM is clearly planning production scale on a timeline of Summer.
I reckon the intention is to achieve approval in major all regions in time for the autumn/winter virus season.
If SNG can be the difference between retreating back into lockdown and staying open that would be a job well done.
Patience will be well rewarded here the next pieces of the puzzle are about to slot into place.
By that logic, which I hope is the case, those that have approved can essentially crack on and get recruiting. That would be the sensible approach. But of course who knows, it may be that hospitals are too overwhelmed right now to swap stethoscopes for clipboards...
*than
They seem to have a two tiered approval process. Regulatory approval which is what we received, but then each hospital’s ethics committee needs to approve too. Five approvals outstanding. I only realised this afterwards. More red tape then the UK!
Doc I think there are many nuances of "NO" or "YES". I would say that asking for the details so late and then saying OK we'll start recreuiting in June, counts as a "MEH". Why is that the case, it is anyones guess.
It appears partially approved, some sites are still under review?
Ethics Committee Maeer’s VishwaRaj Hospital Approved
Ethics Committee of Bowring and Lady Curzon Hospital Submittted/Under Review
Ethics Committee, M.S.Ramaiah Medical College and Hospitals Approved
Institutional Ethics Committee Office of The Principal, College of Medicine & Sagore Dutta Hospital Submittted/Under Review
Institutional Ethics Committee Postgraduate Institute of Medical Education and Research Submittted/Under Review
Institutional Ethics Committee, Fortis Hospitals Limited Submittted/Under Review
Institutional Ethics Committee, King George Hospital Submittted/Under Review
Institutional ethics committee, Medical College and Hospital, Kolkata Not Applicable
Rhythm Heart Institute Ethics Committee Approved
Saveetha Medical College and Hospital – Institutional Ethics Committee (SMCH-IEC) Approved
Doc - hahaha. Funny! It’s Friday so I felt a bit cautiously optimistic, but don’t fret I’m not naive so to fool myself. It was a one off :-) I was merely hoping that was the case. And by no means would I aim to state that as a fact. Didn’t use the words ‘I’m sure’ for no reason.
It's horrible to see what's happening in India but this will be a good opportunity to show the world Sng can do the business with any variant.
India is in a real fix, latest mutation is a killer
The amount of lives that could have been saved both here and in India for example is staggering.
Very sad.
Perhaps the increasing surge in India will give them the focus to rush those approvals through now, get on with it and start sooner. One can only hope.
Scinv_temp - that's true. Guess they don't need to if they can fill the trial from other countries.
I'm sure recruitment is already underway in France, Spain, Portugal, Italy, Serbia and potentially Romania even though their trial registers are not yet fully updated. We know UK, US and Belgium are already recruiting.
Anyone else stunned by the fact that we are now nearly at the end of April and everything is still moving at a snails pace in many of these countries?
Fruitsnveg - don't think so. The trial was first registered on 13 Apr 2021. It seems each trial site's ethics committee independently approves the trial and five of them are still to approve it. Not sure how this affects the trial start date.
Recruiting