Member Info for JoeyDiamond

Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.

https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application

Here is all the relevent info for IND and why its required before you can start the trial.

Lol I wonder if they were meant to put a buy order at 175 and not a sell :)

Certainly looks like 14/15p is on the cards again. Will it hold above this level or is it going to be stuck in the 6 month box range of 10/11 - 14/15 area?

Fingers crossed this time it finally breaks - Golden Summit still had 2.98% holding on 11th Sept at last report so 6 weeks later it is feasible they are now gone.

The most common side effects are pneumonia (4.6%), headache (2.7%) and urinary tract infection (2.7%).

Nearly 1 in 20 get pneumonia as a side effect?

I suspect we are going to get a number of RNS in the very near future.

1) IND application confirmation
2) Various TR1's
3) Phase 3 trial start date
4) Info on EMA or compassionate use in certain countries.

Status
Abandoned

Yes Antonios I would advise you to sell up and move on.

Which seems to show a lack of understanding and foresight.

Reading the experts comments and looking deeper into the trial design it seems to me a waste of opportunity, time and resources.

I persumed the interferon would be used in milder levels of the disease but it appears to have been used in severe disease. S which

Some placees rules

13. it is not acquiring the Placing Shares with a view to the offer, sale, resale, transfer, delivery or distribution, directly or indirectly, of any Placing Shares into the United States and, unless otherwise disclosed to the Joint Bookrunners and the Company in writing, it is not acting on a non-discretionary basis for the account or benefit of a person located within the United States at the time the undertaking to subscribe for Firm Placing Shares and/or Conditional Placing Shares is given;

15. acknowledges that the Placing Shares have not been and will not be registered under the securities legislation of Canada, Australia, New Zealand, Japan or the Republic of South Africa and, subject to certain exceptions, may not be offered, sold, taken up, renounced or delivered or transferred, directly or indirectly, within those jurisdictions and represents and warrants that, unless specifically agreed in writing with the Joint Bookrunners, neither it nor the beneficial owner of such Placing Shares will be a resident of Canada, Australia, New Zealand, Japan or the Republic of South Africa;

This is the confusion on the 180 day number. Its the company that has the rule rather than the placees.

The Company, subject to certain exceptions, has agreed not to allot, issue or grant any rights in respect of its Ordinary Shares in the period of 180 days from the later of the date of Firm Admission and Conditional Admission without the prior written consent of the Joint Bookrunners (such consent not to be unreasonably withheld or delayed).

$300m! Thats far more than what I was predicting on the 100k treatments per month. That would be revenue of $3 billion per year.

Im guessing they are comparing SNG001 to Rebif / Remdesivir to get to this figure?

pmjh you are right all the twitter folks I follow have focused on Remdesivir and to a lesser degree Hydroxychloroquine having no effect. Not one person has mentioned Interferon.

Synairgen are sticklers to detail and from the presentation they advise the trial is a randomised placebo-controlled trial. I be suprised them making a mistake on the trial type.

So this time round the research team know who is getting the drug but the patients won't know wether they have the placebo/drug.

Mentions on the site a recording from the lecture will be available to watch from Monday 19 October.

I have been looking at the WHO Ordinal Scale for Clinical Improvement.

https://static.politico.com/90/c8/aa11d6ef426db2fc9676e3ecc2a6/who-ordinal-scale-for-clinical-improvement.jpg

From the phase 2 hospital arm of the clinical trial we have been using SNG001 on people in the 3-4 range with obvious success. Looking at the Phase 3 design we are recruiting 900 patients that are scored 4 (not 3) on the scale
(ie oxygen by mask or nasal prongs). Looks to me like this trial has been intentionally given the 'tougher' parameter to prove that this drug will be the go to drug for the Mild classifaction of the disease.

This gives you an idea of where the drug is being aimed at, I disagree that it will be aimed at severe disease 5-7.

One quick question. I may have misheard but the virus spike protein is covered in sugar to confuse the immune response. Did I hear him right? :)

What was also notable is another future virus will likely come from bats again, the characteristics will likely be similar to Covid-19 with it able to evade the innate immune response and interferon response.

Makes Synairgens drug future proof for the next pandemic due to its broad spectrum appeal.