Member Info for Soupdragon78

Its down to peoples perception / tolerance to risk, a case of which is likely to come first... ODD news or fundraising news.

Some will have cold feet and don't want the risk of a fundraising being announced before any ODD news, hence they'll sell up now.

The FDA send a letter (by post as the US are quite old school in their bureaucracy) to the agent how are responsible for submitting the application as Nuformix are not based in the US so not allowed to submit the application themselves.

So there is a strong likelyhood that the listing will appear on the database before any RNS.

Magpie, ok, maybe instead of comparing it to last January and a 400% rise, maybe I should have said we're only down to where we were mid December.

I agree LT, like you say logically if there was significant concern then it would likely be rejected at first pass. There is always still some risk of it still being rejected, it would be naïve not to acknowledge that, but the odds must be on the low side imho.

Remember the results show the spending up to the end of September last year. So the increase in spend will have been to get both ODD submissions in.

Steady on... its only 400% up on this time last year.

Just got to sit and wait for the ODD. Nothing else matters at this point in time.

Big_Kahuna, out of curiosity.... 2 weeks ago today you said

"I’m confident that we will have in next two weeks, if not I’ll move on."

As you were buying today, I take it you've changed your deadline?

"If no out-licence, option or collaborative agreement is concluded by the end of March 2026, or the revenue generated by such deal does not provide sufficient working capital to meet the Company's strategy further funding would be required to provide working capital in line with the Company's strategy to fund corporate and operational overheads and to fund further studies before an out-licensing transaction may be concluded."

Cash is through to March sometime.

The year end results will just give cash to end of last september and then a note to say they raised in November, so you'll have to do the guesswork from there.

Notice how the other day Tonto made 10m purchase but did it in smaller chunks so as not to change the price. Whereas someone with followers will want to push the price and will buy in larger chunks to achieve this.

There are certain people playing this, using 4m buys to bump the price then selling into them.

Personally i don’t see any other queries coming forward. Regulators tend to cover everything off in one issue.

The upcoming response will either be positive or negative.

Trans, its literally public info and was widely published at the time of the shut down.

You should have seen it last January!

Its like a Littlest Hobo fansite round here.

Meaning its not got the full FDA IND approval which is required before it can be used in the US.

'IMM did a 10-12x move with approval.'

IMM don't have Orphan Drug Designation for any of their products.

Infor1p, how do you know the company didn't submit the info they used to answer the EMA? They might have submitted the query from the EMA and their response which then the FDA could have asked for further info based on that.

"We will respond to FDA using the data we already have on file, having previously had a similar query from the EMA."

The key word is 'similar'... the FDA is not asking the same question as EMA, they are asking a question that is similar and the company has the data to provide a response.

;-)