ImetelChat

he also said it was a game changer in June

I am suspecting it will be easier to fill this study compared to the MDS study - these patients are in a very bad spot and imetelstat in one of the few rays of hope they have

Looks like they are on the 90 day discussion just occurred for Orphan for juvenile AML/MDS/JMML

Also last month they released a statement regarding Orphan for MDS (which was approved July 27) - the statement also spoke of the need to review for Orphan with MA - I think more is going on than we know

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

https://ec.europa.eu/health/documents/c ... /o2305.htm

this is what i saved end of July

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

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

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...

strange volume on Friday - FYI the EMA CHMP met last week - Sept 13-17 - did something leak from this meeting?

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 ...

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 ...

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

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...

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...

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...

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 ...

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...

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...

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...

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 -