Search found 59 matches

by rccola335
Sat Nov 21, 2020 4:21 am
Forum: ImetelChat
Topic: This was posted last night EU
Replies: 0
Views: 288

This was posted last night EU

this was posted on 11/19/20 - scrolling down to the bottom it talks about reviewing Orphan for MA - wonder why this was posted because Orphan was granted on July 27th
https://www.ema.europa.eu/en/medicines/ ... /eu3202305
by rccola335
Sat Oct 10, 2020 3:34 am
Forum: ImetelChat
Topic: Trying to connect dots that may or may not exist and if they do, they move like the three body problem
Replies: 5
Views: 1551

Re: Trying to connect dots that may or may not exist and if they do, they move like the three body problem

only July 28 the EMA number assigned to imetelstat was EMA/OD/0000031951 - for Orphan for MDS - thats why I think this discussion might of been regarding another drug - unless the number was changed
by rccola335
Wed Sep 30, 2020 5:19 pm
Forum: ImetelChat
Topic: ASH abstracts
Replies: 6
Views: 2052

Re: ASH abstracts

looks like somewhere else ASH says the abstracts will go online Nov 5th - this is similar to 2019 when Geron released this info in a press release - Geron will know next week what they got accepted and for what type of presentation but the public won't know for a month
by rccola335
Wed Sep 30, 2020 5:09 pm
Forum: ImetelChat
Topic: ASH abstracts
Replies: 6
Views: 2052

ASH abstracts

i would assume we will know next week (oct 5th) about what Geron has had accepted for the December ASH meeting - this is from their website: Notification regarding acceptance or rejection of abstracts will be sent to the presenting author in early-October 2020 by email; consequently, an accurate ema...
by rccola335
Mon Sep 21, 2020 3:47 am
Forum: ImetelChat
Topic: CD 47 continued again
Replies: 2
Views: 1533

Re: CD 47 continued again

strange volume on Friday - FYI the EMA CHMP met last week - Sept 13-17 - did something leak from this meeting?
by rccola335
Sat Sep 05, 2020 12:04 am
Forum: ImetelChat
Topic: Orphan being discussed AML/MDS/JMML
Replies: 9
Views: 2500

Re: Orphan being discussed AML/MDS/JMML

the large ATM is only explained by expansion - 3 statistician's - the recent patents - going for Orphan for pediatric AML enforces that plan for for for AML for adult - the amount of capital potentially being raised would be needed for going for the whole enchilada - the full heme spectrum plus the ...
by rccola335
Sat Sep 05, 2020 12:03 am
Forum: ImetelChat
Topic: Orphan being discussed AML/MDS/JMML
Replies: 9
Views: 2500

Re: Orphan being discussed AML/MDS/JMML

the large ATM is only explained by expansion - 3 statistician's - the recent patents - going for Orphan for pediatric AML enforces that plan for for for AML for adult - the amount of capital potentially being raised would be needed for going for the whole enchilada - the full heme spectrum plus the ...
by rccola335
Fri Sep 04, 2020 2:03 am
Forum: ImetelChat
Topic: Orphan being discussed AML/MDS/JMML
Replies: 9
Views: 2500

Orphan being discussed AML/MDS/JMML

the agenda just posted - that month said 30 day discussion and today it said 60 day discussion
https://www.ema.europa.eu/en/documents/ ... ing_en.pdf
by rccola335
Sun Aug 23, 2020 12:19 am
Forum: ImetelChat
Topic: New discussion topic:provocative by design, have at it
Replies: 5
Views: 1525

Re: New discussion topic:provocative by design, have at it

the question is - why did Geron in the spring plan on an AML trial and in June they didn't have the funding? 1- a partnership was planned that fell through 2- felt they had good chance for AA for MF from FDA and ended up with a long phase 3 3 - expected a bigger price jump and therefore a expected t...
by rccola335
Mon Aug 17, 2020 1:15 am
Forum: ImetelChat
Topic: Re EU MA
Replies: 13
Views: 2761

Re: Re EU MA

so the European commission met on June 18th (where they decided to recommend OD) which was released to the public on June 25 and a Geron PR on July 1 - June 19th yahoo writes an article that on the 19th there was a surge in 10 dollar call options for Jan 15th -we aren't stupid - someone got inside i...
by rccola335
Sun Aug 16, 2020 2:02 am
Forum: ImetelChat
Topic: Re EU MA
Replies: 13
Views: 2761

Re: Re EU MA

the main reason i am willing to consider MA a possibility is because one thing I have learned is the system is totally corrupt - when this article came out I scratched my head - you know the only way GERN will surpass 10.00 a share by January 2021 is some type of approval - then when the accouncemen...
by rccola335
Sat Aug 15, 2020 9:06 pm
Forum: ImetelChat
Topic: Re EU MA
Replies: 13
Views: 2761

Re: Re EU MA

67 days for MA is after it is recommended which I think they have around 200 days after applying for it for the committee to recommend also they state before they do MA they consult with the FDA and the Japanese regulatory commission - "in some cases for example when a medicine is intended to treat ...
by rccola335
Mon Aug 10, 2020 12:40 am
Forum: ImetelChat
Topic: Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 1
Replies: 4
Views: 1969

Re: Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 1

I think the italian study which sunk the MOS claim that came out in August 2018 killed the deal - they didn't have time to investigate it to refute it - they weren't ready to marry Geron and declined the scientific wing of Janssen was not in lockstep with the business side - i still remember the sci...
by rccola335
Sun Aug 09, 2020 3:50 pm
Forum: ImetelChat
Topic: Once in a while--hat tip to Fan YMB
Replies: 4
Views: 1772

Re: Once in a while--hat tip to Fan YMB

The percentage of drugs that get EMA OD that go on to get MA is not great - I would attribute this to getting OD early on in the process whereas the Orphan for MDS is later in the process where there is excellent mature data to support MA - also remember there are less options for patients for MDS i...
by rccola335
Fri Aug 07, 2020 12:59 pm
Forum: ImetelChat
Topic: No press release yet
Replies: 3
Views: 1954

Re: No press release yet

On July 1 Geron issued a press release that the European commission recommended Orphan status. July 27th they actually received Orphan status but decided not to issue a press release. Hmmmm.... The stock price was 2.15 on July 1 and now under 1.70. It is almost as if they want to encourage the stock...
by rccola335
Thu Aug 06, 2020 2:57 am
Forum: ImetelChat
Topic: No press release yet
Replies: 3
Views: 1954

Re: No press release yet

someone on yahoo said CG capital and Geron parted ways on July 31 - I suspect it was earlier than that - the PR's in June listed CG Capital on the bottom but after that Geron stopped listing them at the bottom of the pages -
by rccola335
Wed Aug 05, 2020 3:11 am
Forum: ImetelChat
Topic: No press release yet
Replies: 3
Views: 1954

Re: No press release yet

look at the time line for the July 1 press release - june 18th EMA commission met and June 25th they recommended OD - Geron did not release this until July 1 are they waiting for an official certified letter before they publicly disclose? This seems like something you would want a premarket press re...
by rccola335
Mon Jul 20, 2020 2:56 am
Forum: ImetelChat
Topic: I thought this was interesting:
Replies: 3
Views: 1672

Re: I thought this was interesting:

I am expecting the long haul and will consider anything earlier a pleasant surprise - reading that obviously MA is on the table