Member Info for Haywain

Surely there can't be too many shorts open at this point?

Question of the sweepstake - If FDA sends the communication on a Friday and the news is RNS'ed on the following Monday - who takes the accolade : the person who bet on the Friday being the day or the person who bet on the Monday? Personally I factored in the RNS lag to my guess :)

Yeah dont rule it out yet - Friday= FDA's favorite day for communications : not sure if it is to do with the scheduling of their internal meetings but I think >30% of my communications received on a Friday.

I prefer new Vlad

I think that Vlad in the past was a bit naive and someone has had a word about what he puts out there on social media - Now it is the other direction : tight lipped and deletes anything that could in anyway influence investors- I wouldn't read into anything other than RNS

Difficult to tell Catcatbar - Could just be that his tyvek suit is a bit tight... But I am going with smile

Wonder if the lab tour signifies results of in-vivo CBR testing are through?? that would be very interesting

I guess it must have done Chris :)

Totally agree - zero impact on Hemo CAR-T IND : just noise

Thats the thing with new treatments of any type you are never quite sure of the unintended effects of the treatment. That is part of the reason why you run clinical trials in the first place Safety, Efficacy and quality are the considerations in that order. Ultimately clinicial trials are not able to entirely reflect the population of patients that will be exposed to the drug/cell therapy/immunotherapy post approval and as such a post approval system is in place to report back all adverse events - called pharmacovigilance. The data is trended and signals are monitored and will be investigated as to what is the cause for the signal. A decision is then made whether or not any additional precautions or advisory notes should be added to the label or in the case of serious adverse events the over all risk benefit of treating the subpopulation with that drug is assessed. In the case of terminal cancer the risk/benefit to patients is pretty much always going to be positive btu the regulators obviously (and for good reason) take that seriously.

If it is going to be in Northern Ireland vlad can you ensure that the share price is a pound before May please so I can incorporate the party with my annual trip to see the north west 200 - much obliged.

I had to look into my own posting history.... my guess was the 1st Feb too not the 2nd

My comment was more to Dog's query around how many business days Dhub and I think my guess was the 2nd Feb but I have had an FDA response close to midnight US east coast on the 30th day before so you cant really tell when it is going to come - Never had a "late" one yet though.

It isn't business days it is measured in - its a straight 30 days from submission receipt : that being said usually arrives on a business day - FDA typically respond acknowledging receipt of submission and provide a date (which is 30 days from the receipt date) by which you will get an answer sometimes the answer comes before that date and sometimes it doesn't.

In fairness - FDA pretty much always contact you prior to the 30 day end of review period if an issue has been identified for the initial IND review because the issue may or may not be resolvable by the applicant within the 30 day window. They have timeline metrics that they have to hit and they take those pretty seriously.

OK - could you put me down for 1st Feb please

Thanks for the explanation JHFH - Understanding the intricacies of the market is not my strong point. But historically I have been reasonably successful in spotting good science and it has served me well on more than one occasion. My approach to investing is simplistic I buy and hold shares in companies when I like what they are doing - thats it.

Close on 100 million shares

Now now chaps - pack it in : there is no need for bickering after enduring seemingly endless waves of trolls on here over the years we appear close to something really great for the company: lets just see what happens : no need for cat (or dog) fights at this stage.

That makes sense re patient at a time because end to end process + testing needs to be successfully completed for each treatment. From memory they are using the lonza cocoon system so the time could be halved by adding another cocoon system https://www.lonza.com/cell-and-gene/cocoon-platform.