Member Info for Ghia

Alinz - that all I gave true whilst the cash remains within the ISA wrapper.

What many do not realise is that once you withdraw the cash from the wrapper it can be classed as income and thus taxable.

CW25 - Out of interest when the Home trial gets unblinded will your parents be told which arm of the trial they where on?

SNG have dropped Rentschler in favour of Akron Biotechnology.

ARKV - You raise some good points and I would also caution people not to think success at P3 is a forgone conclusion.

Another minor issue is that one of the primary endpoints is time to discharge.

With the NHS under significant pressure you may find that patients get discharged quicker to free up beds for others so this endpoint could be a bit variable and inconclusive.

I’ve no doubt SNG will show a benefit but wether it will be a knock out 79% result like previously is in question.

Jint - This is the response that Timbo (Advfn) got from RM regarding the change of dose. I’ll re-watch some of RM’s videos to see if he references the efficiency of the new nevuliser directly.

“ Phillips and Aerogen have both conducted quantitative scintigraphy studies (using Technicium 99) with their nebulisers to determine lung deposition in human volunteers, the iNeb is more efficient than the Aerogen Ultra, so a two syringe dose through the Aerogen Ultra is 20% – 30% higher than a one syringe dose through the iNeb. Despite the Phase III study using a 20% - 30% higher dose than the Phase II study FDA are okay with this proposal.”

SeaBoy - I think we will get interim results in a similar fashion to P2 this should be enough data for agencies to evaluate the use of the drug in hospitalised patients and draw conclusions on the primary and secondary end points up to the 28day end point.

This is all that will be needed for approvals.

The extended end point data will be useful to evaluate what effect the drug has at preventing long term after effects of covid.

The P2 showed some promising signs that even after the final dose the drug still had an effect.

We will only find out this data once the full peer reviewed paper is released but by then I expect them to be already shipping product.

The long covid data is a nice to have not essential.

Tula - Yes they are doing that too but that will be a function of the Data monitoring committee so SNG will not be told.

After about 200 patients there will be a review at which point if there is an exceptional result in either direction (unlikely) the trial could be stopped SNG will be told at this point a few details of how things are progressing but unlikely to be conclusive at that stage.

Scinv - Access is free you just have to create an account on Advfn and on the general thread for sng request access to the guild and someone will give some coins to gain access.

In the meantime I’ll try and get permission to share the post in full.

Some of the key points:

The dosage is effectively 20-30% higher than P2 taking into account the 2syringes and loss of efficiency in the new nebuliser.

Data unblinding 28days after final patient first dose not waiting to unblind until the long covid study completes.

Anyone with Guild access on ADVFN I suggest you read Timbos post 28772, detailing a phone discussion he had with RM yesterday.

Some interesting answers to some of the scientific detail ref trial changes.

I’ll see if they mind me sharing here.

Hi Gollumk - It was just a joke, cracking RNS I’ll forgive the proof reading.

Synairgen have been busy the past few weeks they’ve developed according to today’s RNS a new formula SNG0011!!

Cracking RNS today an exciting year ahead of us 2021 for many reasons.

The split dosing regime was to account for the reduction in efficiency of the new nebuliser.

The new doses straddled the effective dose delivered by the I-neb.

I’m glad they’ve dropped the second regime since there was a question mark as to how to effectively double blind with the different number of syringes.

The eventual owner of the drug can play around with dosing in the future.

The Job adverts on SNG’s website outline the timeline here.

Seems like they are anticipating huge demand for product end of Q2.

All bodes well, fill your boots this is the real deal.

Hi Woodstock I’m still here took a breather for a while little to add to the discussion until further news.

Dave - Yes but they do not explicitly claim that they are manufacturing X number of treatments.

With that statement they could have legitimately spent all the cash on other supply chain considerations.

Spent part of it on drug product to test certain aspects of the manufacturing process etc.

They did not explicitly claim they would be manufacturing complete treatments.

Versus the latest funding round where they explicitly made the claim of 1000’s of treatment courses which I read as complete drug product and delivery devices sitting on the shelf.

To clear a few things up:

We where not included on the Recovery trial during our original P2 due to availability of the drug. This was identified in meeting minutes.

In the original fund raise £10mil I think it was misconstrued that some of the funds where used to procure actual product. I believe it has since been confirmed by RM that they ploughed the money into certain aspects of the manufacturing process. So they are unlikely to have ended up with complete ready to go batches of product rather they de-risked areas of the manufacturing process.

I expect we didn’t receive EUA because we did not have the manufacturing scale in place. I also suspect some of the delay on P3 is due to the fact they want a statistically significant proportion of the P3 trial drug to be with drug from the new manufacturer this will ease approval.

Cannot stress more highly the importance of doing and owning your own research into a share.

If you had done and backed your own research you would have looked at the 80p share price as the gift horse it was.

Those that filled their boots are now being rewarded as momentum shifts.

Those that listened to the crowd of misinformation spreaders are sadly left licking their wounds and are likely to repeat their mistakes on the next AIM stock they happen across.

It was expected, plus of a population of 330million they will receive 6mil doses in December enough for 3mil people assuming no wastage.

It will be a long time until the vaccines start to provide meaningful change.

Go big or go home!! They are sticking to their convictions as am I.

Beforegolf - There is a concern here for SNG too.

We also require medical grade syringes which RM pointed out where in short supply.

In theory we have booked manufacturing slots for these with some of the placing funds.

However what stops governments enforcing priority to vaccine manufacturing?