bosley
- 20 Feb 2004 09:34
niceonecyril
- 12 Dec 2005 09:21
- 13552 of 27111
Erik,
Its a statuary requirement of 120 days.
Refer to post 1538, investors article 8870#
cyril
Tonyrelaxes
- 12 Dec 2005 09:30
- 13553 of 27111
Is it not that the FDA's statutory period is for them to reach and announce its decision WITHIN 120 days - not necessarily wait until the end of 120 days ?
In other words they have as long as they need , but no more than 120 days ?
tweenie
- 12 Dec 2005 09:31
- 13554 of 27111
Well up 1p already.
whether its a requirement of 120 days or a maximum of 120 days (i think the latter) is hopefully a mute point. Good news this week, hopefully & Roll on the new year . Everythings going GREEN.
BLINGER with Envy. LOL
greekman
- 12 Dec 2005 09:56
- 13555 of 27111
As I understand it re the 120 days period.
At any time during the statutory 120 days the FDA can give NONE approval. But approval can not be given prior to the end of the statutory period. The reason being that the 120 days is the period agreed on in order to assertain any adverse effects. Adverse effects can be found at any period during the 120 day trial, but obviously a set time has to be given for these effects to be discovered. IMHO of course.
niceonecyril
- 12 Dec 2005 10:22
- 13556 of 27111
greekman,
Thats how i believe the 120 day trial works.
cyril
hewittalan6
- 12 Dec 2005 11:06
- 13557 of 27111
Well, Baza,
I hope we get the RNS for year end this week cos I bugger off to Yanksville, USA for my hols on Saturday morning and I won't be back till the new year.
I'll miss all the fun!!
Alan
Red Erik
- 12 Dec 2005 11:09
- 13558 of 27111
Cyril, I agree with Tony
How could the FDA possibly have given the green light for fruit and veg, in a lot less than 120 days, especially when they are only subdivisions of the same application ?
By your thoughts they would have had to wait for the whole 120 days, and they didn't.
I have just checked on the FDA website, and the law states that if the FDA do not object within 120 days the product can be marketed, but as is shown by the fruit and veg, they can approve it earlier as shown here
"Final letter - FDA is not required to issue a letter if it does not object to the marketing of the notified substance. However, FDA realizes that such a letter may serve to bring the review process to closure. Therefore, FDA expects to issue a letter to the notifier that includes information identifying the FCS that is the subject of the notification and the date on which the notification became effective."
Erik the Red
Red Erik
- 12 Dec 2005 11:12
- 13559 of 27111
Alan, are you going anywhere near the Stanelco Inc office ?
Maybe you could pop in and say hello
Erik the Red
hewittalan6
- 12 Dec 2005 11:15
- 13560 of 27111
Dunno, Erik, Where is it????
Alan
bhunt1910
- 12 Dec 2005 11:40
- 13561 of 27111
Alan - I can understand your concern - and if it were me - with your shareholding - I would definitely not be going away to Florida with SEO in such a delicate state of play.
Now I also have some seo shares - but you have been such a good mate over the year and I feel that if it really helps - I would be prepared to sacrifice my own personal arrangements so you could stay behind and so that I could take your place. I do know for a fact that I can cancel my appointments next week - so if you feel the need - let me know and I will reluctantly stand in for you.
hewittalan6
- 12 Dec 2005 11:44
- 13562 of 27111
Baza, I couldn't possibly let you make such a huge personal sacrifice.
How would I sleep on a night, knowing you were being subjected to sunshine, beer and bikinis, while I had the pleasure of a cold Decemeber in Yorkshire, and sitting at a computer doing thankless things for thankless people.
No, it wouldn't be right. I must suffer this personally and view it as a kind of pilgrimage, and the 7.20 I have invested in SEO will have to look after itself.
But thanks for the kind offer.
Alan
ssanebs
- 12 Dec 2005 11:58
- 13563 of 27111
my friend lives opposite the seo hq but they do not like unexpected visitors even though he is a shareholder.
US fda approval has probably already been granted, it was just a matter of going through the motions, as mentioned above it has already been granted approval for fruit & veg.
i think this is the last week for seo to announce the update,(6 weeks prior to the results)
greekman
- 12 Dec 2005 12:05
- 13564 of 27111
Red Erik,
Just read your post which contained this extract.
I have just checked on the FDA website, and the law states that if the FDA do not object within 120 days the product can be marketed, but as is shown by the fruit and veg, they can approve it earlier as shown here .
This now leads me to believe that your interpetation is correct, and mine is wrong ( although still not certain ), re the FDA can aprove in less than 120 days.
Cheers Greekman
bhunt1910
- 12 Dec 2005 13:01
- 13565 of 27111
Alan - - but I insist - I will even make daily reports on the weather and state of the nation !!!!
Baza
hewittalan6
- 12 Dec 2005 13:18
- 13566 of 27111
Oh go on then Baza. Be at Manchester airport for about 10.30 am on Saturday. I'll see you there. I'll be easy to recognise. I'll be the one on the Virgin Atlantic 747 smiling and grinning madly.
Alan
bhunt1910
- 12 Dec 2005 14:11
- 13567 of 27111
touche -
hewittalan6
- 12 Dec 2005 14:22
- 13568 of 27111
Its for the best, Baza.
You'd never cope with my nymphomaniac wife. ;-)
Alan
bhunt1910
- 12 Dec 2005 15:00
- 13569 of 27111
MMMmmmmmmm - now there a challenge
shamona
- 12 Dec 2005 15:20
- 13570 of 27111
greekman
You really let yourself down on the other side over the weekend, pathetic.
greekman
- 12 Dec 2005 15:58
- 13571 of 27111
shamona,
Sorry but I don't agree. If you had seen what I have in my career???. But I am not willing to debate this. I expect posts to be none abusive, not filled with 4 letter words ( not refering to any of your posts ). This is the reason I came over to this site and very rarely post on ' The other side'.