NEU (ASX) Media News

Originally posted by Kjt1969: ↑

Beg your pardon, it was the E&P analyst. In his latest update 3 Feb 2023 he stated he had reduced his likelihood of NDA approval from 95% to 85% due to "concerns around the validity of the RSBQ co-primary endpoint". And he moved from a previously Buy recommendation to Neutral due to the "risk profile of the binary catalyst" of the approval.

Two problems with the above. Firstly, the RBSQ was already agreed by FDA, and met. The idea the FDA is going to change the goalposts after the fact doesn't make any sense - I am pretty sure that is not the way things are done. Furthermore, as a bit of research quickly showed, there was no suggestion by anyone the RBSQ wasn't valid - the E&P guy seems to have caught the same internet meme others briefly caught.

This is not just my opinion. Tanushree Jain of Petra Capital responded "I understand a broker who went from a Buy to a Hold on the stock recently may have provided the rationale for doing that due to questions around the validity of RSBQ as an endpoint for rett. I do not view this as a risk or a reason for the FDA to not approve trofinetide. The fact that the RSBQ measure is not perfect is well known for years but this is what you have at this present time to measure the benefit of a drug for rett and FDA agrees to that and therefore allowed NEU/Acadia to run the Phase 3 trial with that as an endpoint. I also note that in the NEU trial that was a co-primary endpoint with CGI-I and NEU had to pass both with statistical significance to have a positive trial for the FDA which they did. Also more importantly, just last night on the Anavex's call that company mentioned that with the FDA input they are going to use RSBQ and CGI-I as their endpoints for their Phase 2/3 rett trial which has just completed enrolment. I note that Anavex has been trying to get a modified AUC endpoint on RSBQ and CGI-I agreed from the FDA which they used in their previous Phase 2 trial. FDA has obviously knocked that back and told them to use what Acadia did. If there was any doubts around RSBQ and CGI-I for that matter as a valid endpoint from FDA's perspective, this should help to put those to rest."

So the reason he gave for reducing approval from 95% to 85% was not sound.

Secondly, its true there is a binary decision coming up that can go either way. But this binary decision was already coming 9 months ago when he rated it Neuren a Buy. He could make lots of arguments for adjusting his recommendation - but the one he gave does not make sense. He even admitted that his calculated valuation was still the same.

Both of the above changes felt more like kneejerk reactions to me than well thought out reasoning. I suspect he was getting the jitters like the rest of us coming close to approval and scared clients would blame him if his predictions didn't materialize. Mind you, this sort of illogical reasoning isn't uncommon in analysts reports. I remember the Bell Potter analyst who, after strong Ph 3 results, downgraded the approval likelihood to well below the average approval rate because... well - no reason was given for the seemingly random number they changed it to.

All this said, the E&P guys analysis is still some the most thorough out there.

Expand

I don't know much about what happened in that case. Perhaps I should rephrase to say that I'd assume changing the goalposts would be quite uncommon and require special circumstances. There hasn't seemed much evidence to suggest FDA was going to do that for Trof.

No.	Vol.	Price($)
2	1378	$21.24

No.

Vol.

Price($)

1378

$21.24

Price($)	Vol.	No.
$21.29	218	1

Price($)

Vol.

No.

$21.29

218

No.	Vol.	Price($)
1	200	21.240
1	47	21.150
1	500	20.860
1	240	20.800
1	50	20.630

No.

Vol.

Price($)

200

21.240

21.150

500

20.860

240

20.800

20.630

Price($)	Vol.	No.
21.300	12763	1
21.350	30	1
21.380	471	1
21.410	25	1
21.500	60	1

Price($)

Vol.

No.

21.300

12763

21.350

21.380

471

21.410

21.500

(20min delay)
Last $21.27		Change 0.650(3.15%)		Mkt cap ! $2.718B

Open	High	Low	Value	Volume
$20.84	$21.56	$20.76	$7.760M	364.5K

I don't know much about what happened in that case. Perhaps I...

Larvotto identifies new exploration target at NSW's Hillgrove, boosting shares by nearly 20%

Silver Mines models five new calderas close to 396Moz Bowdens deposit

Microcap Wrap: 5 explorers with news out today

Wealth Within weighs in on shock 4% inflation read – and stocks that could survive the gloom

Week 26 Wrap: Cerberus of inflation barks – rents, electricity & fuel – and world watches two elders bicker

Lithium Universe (ASX:LU7) board visits Quebec to engage key stakeholders

Ava Risk Group expands US presence with A$0.7M Substation Deal

Recce's R327 found effective against E.coli during clinical trial

Sun Silver gets that drill to thrill feeling from high grade hits at Maverick Spring

ChemX Materials kicks off first stage works at WA high purity alumina pilot

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

I don't know much about what happened in that case. Perhaps I...

Top Stories

Larvotto identifies new exploration target at NSW's Hillgrove, boosting shares by nearly 20%

Silver Mines models five new calderas close to 396Moz Bowdens deposit

Microcap Wrap: 5 explorers with news out today

Wealth Within weighs in on shock 4% inflation read – and stocks that could survive the gloom

Week 26 Wrap: Cerberus of inflation barks – rents, electricity & fuel – and world watches two elders bicker

Lithium Universe (ASX:LU7) board visits Quebec to engage key stakeholders

Ava Risk Group expands US presence with A$0.7M Substation Deal

Recce's R327 found effective against E.coli during clinical trial

Sun Silver gets that drill to thrill feeling from high grade hits at Maverick Spring

ChemX Materials kicks off first stage works at WA high purity alumina pilot

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News