Nuformix Share Discussion Threads

[volsung] 15/11/2019 12:53

Looks like 8p support to me. But I have been known to be wrong

[galaxy enforcer] 15/11/2019 12:48

Should have waited to buy lower. This is now drifting with next support at 6 pence.

[volsung] 15/11/2019 12:45

Bought back the ones I sold at 9.5p
Hoping for a bounce off the 50day ema.
Fingers crossed

[thefartingcommie] 15/11/2019 12:36

Galaxy Enforcer
Member since: 15 Nov 2019 posts 2

[cottoner] 15/11/2019 12:32

Looking like you want to buy in lower. :-)

[galaxy enforcer] 15/11/2019 12:19

Looking like there is a placing in the wings here. Probably around the 6 pence level.

[soupdragon55] 15/11/2019 09:15

In terms of other cocrystal drugs, Esteve have been developing Co-crystal E-58425 using Celecoxib and tramadol. Not sure where they are at with approval, but they took it through phase 3 trials prior to the revised FDA guidance in 2018

[soupdragon55] 15/11/2019 08:48

"FDA says that co-crystals meeting its requirements are classified similar to polymorphs and are not regarded as new APIs. "From a regulatory perspective, drug products that are designed to contain a new co-ccrystal are considered analogous to a new polymorph of the API," FDA writes, adding that co-crystals that contain two or more APIs are considered to be fixed-dose combination (FDC) products rather than new APIs."

[soupdragon55] 15/11/2019 08:45

Learner, FDA guidance from Feb 2018 sets out how they don't see cocrystal drugs as new API, this means they don't have to go through the same trials as other.https://www.raps.org/news-and-articles/news-articles/2018/2/pharmaceutical-co-crystals-fda-finalizes-guidance

[whatsthepoint] 15/11/2019 08:44

Time to buy pattern has changed bid and offer rising on trades now not falling.

[gibso6767] 14/11/2019 22:26

hxxps://pubs.rsc.org/en/content/articlelanding/2019/ce/c9ce00666d

[learner9] 14/11/2019 21:19

Hi what's the point. Yep, I think you may be correct. The regulators could consider this as a modification to the Drug Product rather than the Drug Substance (API), which could shorten the clinical data needed for approval. Seems to be a different view between US and Europe regulators as to what might be required . And may explain emphasis on going for China approval. Will watch with interest and learn!!. Thanks for the input. Are you or anyone else aware of any other co-crystal drugs that have been approved?

[mars00] 14/11/2019 18:49

Whatsthepoint agree. NXPs are already approved drugs do not need phased approval just have to show that the adapted drug provides benefit it is designed for so only human tests required. This is one of the key differences and benefits of NFX

[whatsthepoint] 14/11/2019 18:27

Learner I think in this instance you are wrong maybe you should send an email and clarify this with the company it may help you.

[learner9] 14/11/2019 18:15

Hi Soupdragon..All new NCE's need to go through Phase 1 to 3 before they are approved. So NXP001 is very early in Phase 1. Even though it is based on modification of an existing, approved product it will still have to be shown to be safe, and have the correct dose established before approval. So you are looking at quite a few years development to get there. The Nuformix business model is to take o make it to POC, then out license. So POC in this case may be Phase 1 but approval after transferring to a potential partner is many years out.

[h0me] 14/11/2019 16:11

Calm before the storm. Pulling in the shares.

[napoleon 14th] 14/11/2019 15:35

Interesting interview, soup.
Thanks.

[whatsthepoint] 14/11/2019 09:21

Very cheap time to get back on board

[gibso6767] 14/11/2019 06:56

Cheers gents

[whatsthepoint] 14/11/2019 06:46

Learner9 News on multiple deals could arrive at any moment hence you need to be in it to win it !!

[soupdragon55] 14/11/2019 06:36

Learner, as they are using tried and tested drugs they don't need phase 2 & 3.

[whatsthepoint] 14/11/2019 05:57

From web site Nuformix's approach uses existing drug molecules, with a history of safe use:No new safety data is required if staying within existing exposure limits, allowing rapid entry to both clinic and marketExisting clinical data better informs decision making in future developmentReduced time and cost of achieving clinical proof-of-concept and increasing success rates versus traditional biotech models

[whatsthepoint] 14/11/2019 05:55

But they don't need to go through phase 2and 3 as known drugs I believe that's their unique USP hence go to market much quicker so not so long term Learner9

[learner9] 13/11/2019 22:48

Soupdragon. Many thanks for posing the link to this talk.