Optibiotix Health Share Discussion Threads

[siennadelekat21] 09/10/2019 07:56

"the market is saturated with this junk and has been for yearssty well away 5p in time"Really Purple11?Can you point to me which other probiotic products have such a pronounced effect on Cholesterol and BP... and are on their way to becoming Pharma grade as well? Sienna

[nobbygnome] 09/10/2019 07:52

>> Glenn

Yes after agreement of the trial design with the FDA.

[glennrcharles] 09/10/2019 07:52

The Gras is actually greener right here for a change.

[asterix96] 09/10/2019 07:49

The GRASs is good for the Bulls but it is going to upset the Bears!

[glennrcharles] 09/10/2019 07:49

So does GRAS status mean that the US company can go straight to Phase 3 trials?

[purple11] 09/10/2019 07:49

the market is saturated with this junk and has been for years

sty well away 5p in time

[parob] 09/10/2019 07:47

The validation of LP(LDL) (R) Pharmaceutical GMP manufacture is a significant step in the development of LP(LDL) (R) as a pharmaceutical drug product.

[hamidahamida] 09/10/2019 07:44

Rampers don't get your knickers in a twist today

[parob] 09/10/2019 07:42

Few marketed probiotics have achieved this level of proven safety and efficacy and it has triggered another milestone payment in the US Pharmaceutical agreement we announced last year.

[buywell3] 09/10/2019 07:39

Re todays RNS ... chew on this

859 FDA GRAS records exist on the FDA database about 88% of which are :

'FDA has no questions' which IMO means passed ok and has GRAS status

About 6% are 'Pending' and the other 6% are 'At the notifier's request, FDA ceased to evaluate this notice (in PDF) (xx kB)'








Generally Accepted As Safe
The inventory of GRAS notices provides information about GRAS notices filed since 1998, when FDA received its first GRAS notice.


So around 800 plus substances have been granted FDA GRAS status with around 50 more Pending


GRAS

In evaluating the safety of the intended use, the FDA considers only safety;
benefits are not evaluated, although health claims may be considered by the FDA under a separate petition process.

[base7] 09/10/2019 07:39

Hopefully while we are all still breathing!

[buywell3] 09/10/2019 07:37

859 FDA GRAS records exist on the FDA database about 88% of which are :

'FDA has no questions' which IMO means passed ok and has GRAS status

About 6% are 'Pending' and the other 6% are 'At the notifier's request, FDA ceased to evaluate this notice (in PDF) (xx kB)'








Generally Accepted As Safe
The inventory of GRAS notices provides information about GRAS notices filed since 1998, when FDA received its first GRAS notice.


So around 800 plus substances have been granted FDA GRAS status with around 50 more Pending

[2vdm] 09/10/2019 07:25

Good news indeed. On wards and upwards eventually.

[nobbygnome] 09/10/2019 07:21

This progress makes the likelihood of getting LPLDL as a Pharma product much more likely. Just think what amount of value for OPTI that is worth..... Oh and another company is paying for all the development and indeed giving OPTI milestones for the privilege. Massive!

[parob] 09/10/2019 07:21

Pharma product de-risked further and another milestone payment received. Wonder if Goetz will update their current price target of 97p given this major step forward.

[sentimentrules] 09/10/2019 07:18

In the meantime well gone 4Dpharma

[parob] 09/10/2019 07:06

Very good news.Steve Prescott, Chief Executive Officer of ProBiotix, commented: "Completing Pharmaceutical GMP process validation and receiving the GRAS notification letter from the US FDA is a significant achievement for ProBiotix and LP(LDL) (R). Few marketed probiotics have achieved this level of proven safety and efficacy and it has triggered another milestone payment in the US Pharmaceutical agreement we announced last year. GMP manufacturing is required to commercialise a probiotic as a drug and is a de facto requirement of many companies to include ingredients in their food supplement formulations. Both GMP manufacturing and full GRAS status increases LP(LDL) (R)'s market attractiveness and shows ProBiotix's commitment to commercialising the highest quality products. I would like to especially thank Dr. Luis Gosalbez who led both processes internally."