Motif Bio Share Discussion Threads

[spmc] 13/2/2019 14:57

Not approved:



Wonder when they will release the RNS

[spmc] 13/2/2019 14:57

Not approved:

hxxps://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=514415

Wonder when they will release the RNS

[bountyhunter] 13/2/2019 14:25

More background...

[bountyhunter] 13/2/2019 13:47

Hopefully there's no storm lol!
...just one big celebration :)

[rizler] 13/2/2019 13:47

Feel like this is the calm before the storm

[bountyhunter] 13/2/2019 13:36

A bit of background reading while we are awaiting the FDA's decision...

[mirabeau] 13/2/2019 13:14

I've never used the order book system as I don't have DMA access but I think they can pull the order instantaneously should they feel the need to do so....I can only assume the 500k sell order is a price blocker for some reason or other..

[andrewsr] 13/2/2019 12:45

Presumably it will either gap higher or lower, so wouldn't you place a buy order just above the current price or a sell order below the price or both? Would buy/sell orders work if it's going to jump or crash?

[bountyhunter] 13/2/2019 12:29

probably worth keeping an eye on both of these

[mirabeau] 13/2/2019 12:06

500k DMA sell order sat at 41p. That's an institution...

[bountyhunter] 13/2/2019 10:24

H2O - just capitalise the leading H to make your link clickable. Is a 'recommendation' for approval of course which I didn't pick up on initially but the timing is still worth noting especially as I don't fancy checking after 9-10pm tonight if we are still waiting!

[h2owater] 13/2/2019 10:23

https://www.prnewswire.com/news-releases/fda-advisory-committee-recommends-approval-of-spravato-esketamine-nasal-spray-ciii-for-adults-with-treatment-resistant-depression-300794493.html

[bountyhunter] 13/2/2019 10:22

Maybe sometime this afternoon if we are lucky,
or even this evening UK time, probably on the FDA site first though before we see an RNS, just not sure which is the best place to look ...maybe this one?

[bermudashorts] 13/2/2019 10:11

Agreed - not long to wait now.

[bountyhunter] 13/2/2019 09:59

I hope we do see news today on Iclaprim but if it's 10pm GMT tonight or even tomorrow I'm not too bothered, the main thing is that we see FDA approval regardless of the exact timing of the announcement.

[bermudashorts] 13/2/2019 09:55

You're not comparing like for like - much better use FDA calendar for PDUFA dates and look back at previous decisions for NME's

[bountyhunter] 13/2/2019 09:49

The timings of the FDA news are still relevant, just check the table I posted and you will see a number of recent delays re 2019 FDA announcements.

[bermudashorts] 13/2/2019 09:47

FDA have NOT approved Esketamine!! You can't draw any conclusions from communication of an adcom decision.

[bountyhunter] 13/2/2019 09:44

Good find H2O I did a search but didn't find that. So could be 10pm tonight the for Iclaprim in which case an RNS would not be until 7am tomorrow.
I realise it wasn't actually the FDA approval on rechecking but the timelines of the news are still relevant.

[alexios1201] 13/2/2019 09:42

Safe targetsAll time high 75.5pCash 3.7p equivalentHope it is approvedGood for the markets

[h2owater] 13/2/2019 09:33

Yesterdays FDA approved esketamine drug at 10 pm UK time(esketamine) Nasal Spray CIII for Adults with ... - Johnson & Johnsonhttps://www.jnj.com/fda-advisory-committee-recommends-approval-of-spravatotm-es...8 hours ago - FDA Advisory Committee Recommends Approval of SPRAVATOTM (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant ...

[bermudashorts] 13/2/2019 09:32

longshanks - sorry posts crossed

[bermudashorts] 13/2/2019 09:32

bountyhunter,

The event yesterday for J&J's depression drug Esketamine wasn't approval - it was an adcom meeting. Adcoms are scheduled when the FDA has received an application for approval but requires further information before they can reach a decision. So a meeting of an independent panel of experts is arranged to give their opinion. The Adcom for Esketamine took place yesterday and the panel recommended the drug for approval - it will now proceed and final decision will be made by PDUFA date which is 4th March.

The FDA didn't require an Adcom for Iclaprim.

[longshanks] 13/2/2019 09:24

Esketamine was due to have a panel review by yesterday, which they got.FDA decision on Esketamine is due by March 4th.

[bocase] 13/2/2019 09:24

Yes with a six week US shutdown it is not surprising that they are running late.