35 Days since CHMP + Reco

[Ryan]

Read that EMA typically takes 30 days to grant or deny marketing authorization. So I suppose next week, it will be imminenter than imminent…

[Zhears]

From Chat GPT, the min number of days was 30, they can go up to 67 days legally.
Since we had the holiday season in the middle it will probably add a week or two.

However - The 67-day timeline for the European Commission to adopt a decision after a CHMP opinion is counted in calendar days, not working days.

So 18 Feb is the deadline.

With the share price tanking, its hard to believe that approval is baked in.
*edit. I suppose approval isn't baked in because in effect there is no money coming in from it yet. Individual countries need to do there own paper work which can be another 6 months and we don't as yet even have an idea of which places are going to be targetted.

[biopearl123]

Zhears, they have guided that they don't plan to market until 2026 in Europe, so all approval does is make the company more valuable to a potential buyer. British Isles remain a black box.

[kmall]

Bp & Zhears - Courtesy of InfiniteLiquidityFairy over on Stocktwits......

InfiniteLiquidityFairy
36m

$GERN pure options manipulation here for the past few months to close below 3 for todays(jan 17) expiration. They (MMs) wanted it below 3 and def below 3.5 and 4 to avoid a potentially having to go in and buy ~2 million shares that frankly don't exist freely at this point with 95% institutional ownership and 70mil shorts. Hopefully the games are over and we can move up from here because we all know the big money don't lose and they are patient while they(blackrock & Vanguard) lend their shares to their HF buddies and they short. Eventually this will pop and I'll be here. Long term holder.


https://stocktwits.com/symbol/GERN

It's fairly obvious that some serious shenanigans are underfoot..... been this way for as long as I've been around, but if I had to guess I would say InfiniteLiquidityFairy has his finger on the trigger here. These big boys MAKE $$$.....that's what they do. Good chance they're shaking out weaker small institutions with stop losses, since most weak retail hands have undoubtedly flown the coop....only the serious stubborn or really really stupid left (I feel like I'm half and half in each camp there). I think I'm gonna go watch Super Dave Osbourne now. -Kmall

[Ryan]

Thanks for the additional info.

I’ll be looking for the company earnings release date as a cue

I suppose the drop dead last date bears well for the Feb options, which expire the 21st next month…

[kmall]

Zhears - I believe Geron has prepared for the EU launch to a certain extent as far as it will benefit the company financially. As you pointed out, a lot of hurdles as far as individual countries go. And from what I understand, they plan on targeting the big 4* first: Germany, France, Spain, Italy (*it used to be 5 before the UK went feral), which compromises the majority of potential EU revenue tied to MDS.

On December 4, from the Evercore fireside chat, both CFO Michelle Robertson and Dr. Scarlett touched on glimpses of their game plan moving forward in the EU and it sounds as if they will be subcontracting established vendors to facilitate and streamline sales - a bit of speculation on my part, but this is a small excerpt of highlights from that conference I posted back on 12/4/2024:


"Three interesting points I found here all pertaining to the highly anticipated EU commercial launch. For obvious reasons, a much different scenario then the US:

1. Geron is "talking with external vendors" in the EU. (Robertson)

2. "As a single product company, not investing heavily" in the EU. (Robertson)

3. "Not an attractive market to give to someone else." (Dr. Scarlett)"

http://imetelchat.imetelstat.eu/viewtop ... f=1&t=2167


Bottom line in my view: No Ex-US Partnership as of now, external vendors already entrenched in individual countries to expedite sales and Geron being financially conscious of the marketplace in Europe to maximize potential revenue. I think the drop in the SP these past few weeks is tied to the points listed in my response here in the thread above. Hopefully we move up in short order.......in the meantime I'm still watching Super Dave as a comedic distraction. -Kmall

[Zhears]

Random thought and question to chatgpt.

Is there a particular day of the week that the decision is announced?

ChatGPT said:
Yes, the European Commission (EC) typically announces its drug approval decisions on Fridays.

This follows the CHMP’s positive opinion, which is usually adopted during their monthly meetings (held Thursday to Friday, typically the third or last week of the month). The EC decision then comes within 67 days, often aligning with a Friday release.

So it should be this Friday.

[bucbeard]

also, keep an eye out this week for GERN filing on annual stock option awards. if that happens at this current price, an EU decision could be forthcoming.

Chippy and crew need to load up...again.

[jayfish101]

Thanks, Zhears. Great sleuthing! I bought some more today in hopes of a Friday pop.