Member Info for ChrisToffer

Thanks Millie, it does stand to reason that people involved with our major shareholders may have connections with the 3rd party that is running with the licencing process.

You're such an obnoxious prick Scinv! You even managed to make a compliment sound pompous haha

Hi BF, itll have to be tested very carefully on ventilated patients. Although the P2 results suggested benefit later in the disease there is a greater risk of co tributing to cytokine storm. I think progress in that direction will be slow however if the drug is administered early enough it may not be needed there anyway.

Mechanical ventilation is still off at this point! According to the EU register anyway. The focus is OSCI 4 which is oxygen but not mechanical ventilation as far as I'm aware.

Thanks CW/Oxford, it is a good question but it prompts a further question in my mind. Why would a negotiating partner want to remain anonymous? Surely an ongoing licemcing process thats played out in public would benefit the company/partner as it would raise the bar?

Thanks Meelie, feel like I've answered that question a few times already, nice to have the quite to hand!

Shan, the brokers reiterated their targets post vaccine news.

Thanks Jint, the FDA website is a very good resource for this https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishment-and-operation-clinical-trial-data-monitoring-committees.

It appears the Activ trials keep a close eye on whats going on in order to expedite, or stop, trials that are showing promise or not.

Hi Bella, it deffo feels like the entire US venture has been played down. Would a change of trial focus (in that direction) go some way to explaining the prolonged silence?

Chill out ZK Ffs

Doc, I think RM said that the UK sites would start first 'in the coming weeks' and the rest would follow.

Org, how can they possibly fill recruitment numbers before they start? If the first patient is in the trial entry criteria (i.e very ill and in hospital) do you think they're going to wait for the other 899 patients before starting?

You've lost the plot Axe! filter me if ya like but you've got the wrong end of the stick on this and you're the only one holding it.

Someone emailed consilium around the time of the SG016 update to query the 820 patients and they were told it was an administrative update. There is still a mystery around it as it also mentions a pivotal arm which would suggest a faster route to approval than a full blown P3. However we can probably assume that the announcement of a P3 and subsequent cash raise supersedes any previous route to approval.

SG016 continues with the home arm and the company would have to be clear if they were still recruiting in hospitals for P2.

Axe, Phase 2/SG016 is still ongoing with the home arm.

Axe, that was last updated on the 27th August long before SG018 even existed. If you read it all (buddy) it even says SG016 which is the P2 trial.

Antofelli Filtered.

Axe, the first link is to SG016 which is the P2 trial. The second is SG018 which is indeed the P3 and it does say ongoing, however it has always said that. The company have not announced the first dosing which is a huge milestone and therefore will be RNS'd.

Shadowboxer filtered. What a waste of good oxygen!

Depends on the content of the P3 start RNS. It's no secret that the company have been in ongoing discussions with the FDA so if that RNS includes a positive IND update, or conditional orders, then it's possible we see the placing price before the next readout.