Polarean Imaging Share Discussion Threads

[acuere] 06/10/2021 12:01

Alloa, from the HY report on 2nd Sept.

“Frequent interactions with the FDA as they review the NDA in advance of our TARGET PDUFA goal date of 5 October 2021”

It may well be that at cob US time on the 5th, FDA did email a response to us, and CEO, brokers, lawyers have spent this morning draughting a legally compliant RNS.

Tbh, as a lth, I get not if we hear today ,tomorrow ,or next month as long as it’s positive.

[alloa2003] 06/10/2021 11:24

Acuere - the 5th October was mentioned as THE date when they would get the ruling from the FDA, there was no indicitive date. The CEO even went on to say that if they werent going to get a ruling on the 5th, the FDA would have been in touch to advise them of a delay, and they hadnt. So, no, I am not buying that it was indicative, it was set in stone by the company.

That said, the interview a few weeks ago was very impressive and he knows what he is doing. We all know that companies have no control over FDA timetables.

[red171] 06/10/2021 11:22

This is the text I googled on reliability of PDUFA deadlines:

The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications,[1] and while there is no official list of PDUFA dates,[10] several websites collect PDUFA dates from press announcements in a calendar form

There could be reasons for announcement taking a bit longer as many have said here including Covid backlogs even with what alloa says about CEO references to 5th Oct. The CEO must be hugely relieved not to face an unaccountable end date where only 40% are notified on time as before PDA, I expect it will arrive in due course.

GLA

[emmjam] 06/10/2021 11:21

Why chase yesterday ? The FDA is in the US, 5 hours behind us (HQ in Maryland anyway), and they had until close of business their time, not ours. To chase them before that is a waste of their time and ours. By all means chase them today, but thats only possible when they open, possibly in 2 hours time, maybe 3

[neo26] 06/10/2021 11:18

Hopefully later today we hear something

[acuere] 06/10/2021 11:16

neo, you don’t go chasing them up until it’s late.

[lippy4] 06/10/2021 11:13

its worth the gamble to hold in my opinion, thats me though its up to the individuals risk fear..

[neo26] 06/10/2021 11:08

Yes it was, they ahould hav been chasing up yeaterday.

[acuere] 06/10/2021 11:06

The 5th Oct has only ever been mentioned as a target date. Presumably as that was the date the FDA indicated to Polarean. Target dates are regularly missed.
From Polarean side, if nothing heard they would not be able to chase up the FDA until this morning and wouldn’t to get a response before lunchtime at the earliest.

I suspect a lot of punters, in too deep, had a sleepless night and sold first thing on the back of no news.

[alloa2003] 06/10/2021 10:51

The crux of the problem here is that the CEO mentioned 5th October time and time again in interviews as D-Day. In reality he has no control whatsoever on FDA timings as everything seems to be indicative. If he had said FDA approval was expected in final quarter of 2021 then expectation would not have been so high.

[neo26] 06/10/2021 10:17

If that was the case they should have informed them on pdufa date.

[haroldthegreat] 06/10/2021 10:00

FDA likes to delay UK applications . Look at how they delayed UK applications for generic seretide inhalers .

[radderssandy] 06/10/2021 09:49

Thanks Tutte for a measured & reasoned post. And agreed Raftboy, whilst the delay is uncomfortable we are definitely not out yet.

[moontheloon] 06/10/2021 09:13

This is why you should post more when sense needed tutte :)

[w t tutte] 06/10/2021 08:48

Again looking at things logically, we know it is almost impossible for there to be a safety issue as it is an inert noble gas and the comparator is a radioactive isotope of itself. We also know there can not be an efficacy issue, as again it only has to demonstrate non inferiority, essentially to the same gas. So if there is an issue where could that be ? it is hard to see anything in the study implementation or design that might cause problems and these would have been picked up a long time ago. So if there ends up being a delay it might be in the paperwork related to GMP 21 CFR 820 Good Manufacturing Practices on tractability and audit. If there is an issue here it is sloppy but fixable. I remain convinced approval is close.

[rafboy] 06/10/2021 08:37

There is no bad news as there is no news. Delay is uncomfortable but we are not out yet.

[markstevenkirby80] 06/10/2021 08:25

It's a buyers dream

[volsung] 06/10/2021 08:24

Bought a few more at 92p
Keep the faith!

[jaforsadi] 06/10/2021 08:23

Isn't looking good

[neo26] 06/10/2021 08:23

The company would have definately heard something by now.Rns needed of whats going on..

[oapknob1] 06/10/2021 08:19

Unless JW has bailed already

[moontheloon] 06/10/2021 08:14

Thanks for your insight tutte

[actybod] 06/10/2021 08:08

Agreed - it's a big RNS

[w t tutte] 06/10/2021 08:08

The only upside to this tension is that XXXX Justin Waite must be XXXXXXX bricks !