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agreed in terms of definition - but the application still would need to reach demanding de Novo standards....
anyway, we both agree that this no longer applies, I'm no longer worried about it, and perhaps my earlier fears were unfounded :-)

Phantom, I don't believe they could - but my fear was they might respond: 'application doesn't meet the necessary high threshold for De Novo' or some such nonsense (if I'm being cynical). Now I don't feel they could.

clearly we will need a timely resubmission confirmed first Div - then the 'anticipation' move up (which is already part of the current SP, we should remember) will be boosted by clinical news and probably another research paper. I would see the Broker target of 150p as an ideal launch pad, but we may not quite get that far - 140 ish would do me. FDA approval would then propel the SP toward £3, allowing it eventually to settle around £2.50 for the next phase of the grand plan toward £4, and then £8. (my top slice target price). Others I know see £10 and £12 and £20, which is entirely possible, but by then I'll have a modest holding.

and what kind of hit might that be PJT?
FDA have worked with the company through an interactive Q submission for over three years.
They have assessed the whole application, then sent a request for more detail, which we trust the company will return shortly.
Are FDA at that point going to say "oh, sorry, the application has been rejected"?
The big danger for me was the De Novo status - I think FDA may have been justified in saying "product is good but we are not convinced about De Novo status" but they surely could not state this after a request for more detail?
so for me the only remaining danger is a further short delay - "extra detail insufficient, please provide more" and thus add another 6 weeks to the time frame and knock the share by 20% for a week or so.

it's an important point Bojo - many trader types will consider selling on FDA approval, but it is the starting block not the finish line.

first one of the expected two I mentioned last week - intriguing new application offering new revenue streams. They are going to need more clinics.

it made me giggle PJT (no offence intended) - "all due haste" is perhaps what you were thinking, which I'm sure is the case. Knowing the way Angle operate these days, they will be finalising the response today and tomorrow, and we should get an RNS Wednesday or Thursday, so I'm predicting £1.20 by Friday. (not that it matters...)

ha ha PJT - maybe you should check the definition of "haste"!!

I think an RNS will come next week - a timely response will firm up the SP ready for a jumnp on second clinical contract - forming the base platform for FDA clearance.

Nightmare, what's the lowdown (and the ticker) on Affirm?

good to see you both feeling positive going into the weekend - next week is ripe for an RNS - either re-submission, or second clinic contract. Both maybe :-) GLA

yep, but that's the markets for you - look at Dogecoin (or Tesla etc etc) - there's a Bear move on Pharma in play at present, diverting money toward consumer-facing companies post-Covid. It will take some news to bounce them out.... meanwhile, cheap stock ahoy! (I filled my boots at 99p)

we will certainly be told about the resubmission - and reminded of potential FDA slow response, though I'm not so sure it will be that slow, personally.

maybe the date of the RNS release needs a poll as well?

May 24 for me

leave it out GL - takeovers have only been spoken as future possibilities, definitely post-FDA. The current SP, or 5% up or down, is insignificant to LTHs, which is why you've not found much material to work with on here.

on which note, has Darren got his 55p buy-back yet?

it shouldn't really matter who the pharma is, as contract value will be key, but clearly any AZ connection will have an instant impact on the SP. Div and I have previously noted a number of 'coincidences' pointing in that direction, so let's wait to see who is right shall we...

all three we hope yuyus - I'm thinking you'll get a birthday present this year!

I can't see FDA resisting the submission much longer, and there will certainly be capacity in the clinics (25,000) - as to Nasdaq - that needs to be well-timed - after all, US investors are all over this share at the moment so it's hardly a priority....

sorry, but only 90p from me

yes the peer reviews are outstanding Bojo, and put AGL in a class of its own - whether the FDA are capable of rejecting the submission of course remains to be seen, but it would certainly damage the FDA's reputation, as they have worked so closely with the company for so long.