Member Info for Sangijuelas1

Why do you choose not to address the points raised and perhaps offer a counter view?

If the FDA make a distinction between an expanded access programme and a clinical trial, why do you think that Tils feels the need to erase this distinction?

Why would people be scared because someone is questioning the way information is provided in an RNS?

Maybe investors need to 'be scared' sometimes if it leads them to evaluate the quality of their investment rather than just relying on others on a BB to tell them how wonderful the company is.

For a look at the fallout from such a situation check out the likes of Hemo and the people calling for the blood of the rampers on that BB.

Especially when you realise that the boosters have no idea what a clinical trial actually entails.

There would need to be an RNS though

I actually think you are cursed Xenor and you are what is holding down the price.

If you sold out it would be 500p in no time!

I am still here. Looking forward to the presentations.

Are you really not familiar with US ambulance chasing lawyers?

And if that's all you can find to knock 4D, well!

I am going now. Wasted enough time here.

What trials are you talking about Cloudy?

Yeah there's an investor conference call today to discuss results of Blautix Phase 2 trial presented at the Digestive Disease Week conference at the weekend. And to cover plans to start the Phase 3 trial.

Tomorrow the US broker Ladenberg Thalmann is showcasing the company with a discussion of the 3 ongoing oncology trials and potential for FDA fast track approval . They were very nice brokers. They gave us an independent broker note unlike the Zacks note that Tils had to pay for.

Also they can't just add patients. Each one requires specific approval.

"A12: Each request for individual patient expanded access to a drug should be treated as a unique clinical situation, and the risks and benefits should be evaluated based on that clinical situation. Even when there are two (or more) individual patient expanded access requests for patients with the same disease or condition, there may be significant differences in the clinical presentation of the disease or condition that make the risks acceptable for one patient, but not for another. For example, a patient may have a different stage of the disease or different tumor type than previous patients who were permitted expanded access to the drug and, therefore, may have a different benefit/risk ratio. Similarly, a patient may have a comorbid condition not present in previous patients who obtained expanded access that would make the risk unacceptable. FDA may also become aware of new safety signals or information about effectiveness that changes the benefit/risk ratio such that the risk is no longer acceptable for the patient. In cases such as these, individual patient expanded access for additional patients might be denied."

More from the FDA

"Expanded access refers to the use of an investigational drug when the primary purpose is to diagnose, monitor, or treat a patient’s disease or condition rather than to obtain the kind of information about the drug that is generally derived from clinical trials.

The main distinction between expanded access and the use of an investigational drug in the usual studies covered under an IND is that expanded access uses are not primarily intended to obtain information about the safety or effectiveness of a drug".

"Whenever possible, an investigational medical product should be used as part of a clinical trial. However, if patient enrollment is not possible (e.g., patient ineligibility, lack of ongoing clinical trials) or enrollment in a clinical trial is not feasible (e.g., distance to a trial precludes access), expanded access offers a possible route for gaining access to an investigational medical product".

https://www.fda.gov/news-events/expanded-access/expanded-access-information-industry

Nomad not needed as no longer on Aim so ignore

From the FDA

Expanded access may be appropriate when all the following apply:

Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
Patient enrollment in a CLINICAL TRIAL is not possible.
Potential patient benefit justifies the potential risks of treatment.
Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

https://www.fda.gov/news-events/public-health-focus/expanded-access

You are the one not listening Cloudy.

Clinical trials are not run like that.

Strange that none of the RNS have details of the Nomad as you would normally expect.

Just GC and Red Chip

No it won't feed into FDA approval. Dosing 1 patient will produce an anecdote not proof of concept

Because the patient signs a disclaimer saying that they are aware that they are taking an experimental drug that has not been approved in clinical trials and are aware that it could make them very ill.

Calling dosing one patient on compassionate grounds a clinical trial.

How can they do that?

I hope I didn't come across as rude. Certainly wasn't intended that way.

It's funny how rude some people get when you ask them a question they can't answer.

I was challenging the investment case for Avacta a few months ago and asking questions like this as I thought there seemed to be uninformed optimism about their cancer therapies. Most posters took exception to my posts but some addressed the questions raised and their answers caused me to invest more money in the company.

That is not happening here except one point made the other day about Foralumab and the BBB.