Evgen Pharma Share Discussion Threads

[amaretto1] 02/9/2021 10:10

Yes ... no problem !

[demark] 02/9/2021 10:09

surely some ground
breaking rns could be
on the cards!!

any in-house experts to
comment on the following
please:

between 60p and 76p
banding that values EVG
between £165m and £210m!

could this outfit be
worth that much?

[mr greedy1] 02/9/2021 10:03

The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.

A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information in support of their designation request. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.

[alancapone] 02/9/2021 10:01

Quick reminder as to potential price targets.

[on target] 02/9/2021 09:58

Approval is what happens at the end of clinical trials Ged, when you want to release a drug on the market.

[ged5] 02/9/2021 09:56

So this news is about designation not approval. Great news but it looks to me that approval could be six months.

[jusjusjus] 02/9/2021 09:49

surely Evgen have to release an RNS now?

[amaretto1] 02/9/2021 09:49

What news ? Have we had a RNS ?Bit of a silly statement

[on target] 02/9/2021 09:48

Well hopefully we'll get one at some point today Brasso!

[brasso3] 02/9/2021 09:45

I would have expected a bigger rise on the back of this news. Lets hope for an RNS tomorrow...

[garth] 02/9/2021 09:07

If one could buy any at this point it would be at placing price...

G.

[moneymunch] 02/9/2021 09:02

Not many shares in free float...Mr Kight has bought them all. Gla :-)

[moneymunch] 02/9/2021 08:51

Lol...this is big news and the market is unaware. Fill ya Boots!!! :-)

[amaretto1] 02/9/2021 08:16

We all have !! Glad to see you on full ramp mode today

[moneymunch] 02/9/2021 08:10

HOT OFF THE PRESS....FILL YA BOOTS!!! ;-)




FDA grants orphan drug designation to sulforaphane for malignant glioma (6.4000p, 0)
Wednesday, September 01, 2021 10:05:51 PM (GMT)

According to the FDA's Orphan Drug product website, Evgen Pharma plc has been granted Orphan drug designation for Stabilized sulforaphane for the treatment of malignant glioma.

Designation date 9/1/2021

StreetAccount notes that the name of the drug was not disclosed, but that it is likely SFX-01. Evgen's website notes an ongoing collaboration with a prominent European university in which highly positive data for SFX-01 was generated in preclinical models of glioma.

FDA orphan drug designation is primarily a function of the disease not the drug - drugs that target diseases with fewer than 200,000 US patients will be granted orphan designation, and in some cases drugs targeting more than 200,000 patients can be granted the designation when the FDA judges that costs could not otherwise be recovered.

[amaretto1] 02/9/2021 08:09

Yes bid !!

[amaretto1] 02/9/2021 08:09

6.50 on bid !

[moneymunch] 02/9/2021 08:08

"No live quotes" to buy!!! ;-))))

[amaretto1] 02/9/2021 08:04

Wanting serious premium for volumes on the offer ....7 pence for 100k

[on target] 02/9/2021 08:02

Can't link directly but put in yesterday's date on the search page and there it is :)

[on target] 02/9/2021 08:01

It's there, just found it :)

[moneymunch] 02/9/2021 08:00

FOUND IT!!!

[moneymunch] 02/9/2021 07:55

Hi peanut, have you got a link to the article please, as the only one i can find is the following for Lantern Pharma....just a coincidence!!!???

FDA Grants Orphan Drug Designation to LP-184 for Malignant Gliomas
August 31, 2021