Do NOT sell

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phil
Posts: 16
Joined: Wed Dec 09, 2015 2:53 pm

Do NOT sell

Post by phil » Fri Aug 24, 2018 3:58 pm

Congrats to all holders. While there are some that expected a positive CD, still not yet announced, NOBODY is expecting drug approval, which by the looks of things is happening in EU. 60 million shorts are in for a VERY rough ride. This is when the smart money buys and small retail sells. I'm adding all morning.
For what it's worth
Phil

biopearl123
Posts: 223
Joined: Fri Jul 20, 2018 5:13 pm

Re: Do NOT sell

Post by biopearl123 » Fri Aug 24, 2018 4:08 pm

Phil, thank you. Your track record is pretty pretty good (to quote Larry David). It does look like there is a lot of interest in Europe. Interestingly the job posting at Janssen does not mention MF but emphasizes MDS and AML (!) in patients not eligible for induction. Perhaps MF approval is a forgone conclusion by the FDA but not so much by EMEA. Please continue to share your thoughts. The next few weeks will be interesting. bp

phil
Posts: 16
Joined: Wed Dec 09, 2015 2:53 pm

Re: Do NOT sell

Post by phil » Fri Aug 24, 2018 4:36 pm

When Olivia said that Geron was stopping the ATM, that was a clear buy signal to me as there are sooo many shorts out there, that was the best opportunity to buy (no more supply and possibly large -60 million share- demand). This new news is also good, but different, it seems like confirmation that JNJ is in fact continuing, but more so, when talking about "pricing" in their application, it sure smells like EU approval is either imminent or has been granted.

The AML news is also very positive and unexpected. The non-MF news isn't a big deal because I didn't expect anything more than a new P3 soon, I think we need to wait and hear what JNJ says their plans are for MF. Remember it was the clearing of bone marrow that got them so interested in the first place, so they might go after front line and I'm looking for a MF trial starting in 2019, not in R/R but earlier stage MF.

I have always owned the stock (contrary to what some have said), yes I have traded it because that is what I do, but bought more pre-market today and waiting for pullbacks to add. I don't think this explodes just yet, but hard to see it going down under $4. I don't know of any analyst (other than some commentators in SA) that foresaw EU drug approval, and that is what this smells like to me.
P

phil
Posts: 16
Joined: Wed Dec 09, 2015 2:53 pm

Re: Do NOT sell

Post by phil » Sun Aug 26, 2018 6:26 pm

The cat is out of the bag...
Those who followed the story closely know that European approval would come first, and this "slip" and job posting is VERY SPECIFIC, looking like MDS and AML will be the first indications targeted by Janssen- and in Europe. When Janssen/JNJ go in, they go in BIG TIME and this is just the start of multiple indications to come, my guess is we have 4-5 trials by end of next year and it looks like a very good chance that we see some actual sales and revenue. This is a "news slip" to take advantage of.

Obviously there has been chatter on SA about the 68 year old GC's stock sale, which is just verification to me that those at Geron didn't know for sure if JNJ would continue or not, so Scarlett raised some insurance money (ATM) and the GC put a limit price to sell at a price up30%, my guess is he retires soon. So what, he is the corporate LAWYER, he CAN'T trade on negative inside info, he wold go to jail, without passing GO.

This positive continuation decision just went from 75-80% to 95%, at least in my eyes. Look at MDS and the specifics on AML, this is not some arbitrary job posting, it is VERY SPECIFIC on VERY SPECIFIC indications, JNJ knows exactly what they want to do. They will go after MF next. The posting has not come down. Janssen is able to and has been doing clinical work behind the scenes in Europe- that was not disclosed in the u.S.
Janssen is moving forward.

biopearl123
Posts: 223
Joined: Fri Jul 20, 2018 5:13 pm

Re: Do NOT sell

Post by biopearl123 » Sun Aug 26, 2018 7:31 pm

Hi Phil, thanks for posting. I couldn't agree more with your assessment. EU approval has been telegraphed. There are a few mysteries worth examining. The GC's sale is not one of them for all the reasons you enumerate. Scarlett has acted as if he remained uncertain about the CD, but of course he knew but played it so close that even his GC took out an insurance policy. Now that's pretty good. The mysteries: 1. Is the EU ready to approve in MDS based solely on the phase II data? This is a very small study, but if so the data must confirm the very impressive MDS presentation at ASH. Some provisional approval seems likely with a mandate for further study (like a US phase IV). Mystery 2. The clear indication of forward clinical development in AML. This is worth looking at. Phil and others help me with this. As I recall the ONLY patients who have received therapy in AML were the Tefferi patients, and that was an extremely small subgroup (two patients?). Dr. Lane's studies, while very impressive were limited to the lab, I do not recall any patients under his care actually receiving drug for AML. Janssen would have to be pretty sure of themselves to seek approval in this indication unless some simultaneous study/approval path existed. I as yet have never heard of such a thing. (But am open to the possibly of a surprise!). To me this implies that the closely held MF data must be showing an alteration in the natural history of progression from mod/high risk MF to AML. Assessment of this known natural history is a secondary end point in the MF study and if MOS is altered some signal re delay or avoidance of AML is likely. Perhaps this data forms the basis for non inducible AML indications? If so it implies that the MF data, heretofore underemphasized and doubted by some, might be pretty pretty strong and form the basis for an impending FDA approval in the R/R indication. Clearly the OS data is strong and should form the basis for FDA approval. Why the glaring omission on the European side? Is MF approval in the EU implied by the presence of a plan to go forward is a small subgroup of AML? The plan for MDS and even AML appears clear. Why the obfuscation regarding MF in the face of glaring MOS data? I totally agree that some approvals and many new studies appear to be on the horizon. Best Regards Phil and thanks for sharing your thoughts. bp

Dogonenuts
Posts: 40
Joined: Tue May 10, 2016 6:13 pm

Re: Do NOT sell

Post by Dogonenuts » Sun Aug 26, 2018 11:43 pm

Biopearl,

As crazy as it sounds, I wonder if a lot of the questions you pose would not be cleared up were it not for th ASH info embargo. It is really unethical that the surprise value of a medical meeting would come before freeing up a new medication that might save a few lives between now and Dec. We may get a CA, but still be mushrooms where it comes to knowing a lot of the info Janssen has at this point.

huntingonthebluffs
Posts: 139
Joined: Wed Feb 24, 2016 12:00 am

Re: Do NOT sell

Post by huntingonthebluffs » Mon Aug 27, 2018 9:35 pm

While it may not eliminate any concerns or completely satisfy any of us, I thought I should probably share the response to my email to IR at Geron re: Mr. Rosenfield’s options sale. It is essentially the response I was expecting while hoping for more.

My question was: I was wondering if there is an explanation the company might share as to why the Geron General Counsel would exercise 75% of his options given the JNJ CD is imminent and all signs point to a positive action and expansion of the Imetelstat activities. There must be an explanation available to shareholders due to the timing of this sale. Thank you.

The response was as follows:

Mr. Rosenfield's options were executed as the result of a 10b5-1 plan. In accordance with the guidelines specified by the SEC’s Rule 10b5-1 as well as the Company’s Insider Trading Policy, Geron has established a 10b5-1 program that allows officers and directors to enter into pre-specified trading plans to sell Geron stock over time as part of individual asset diversification plans.

Rule 10b5-1 plans permit directors, officers and other company insiders to adopt a pre-specified future trading plan in a company’s stock while they are not in possession of material non-public information. The plans are used to diversify investment portfolios over time. As such, trades under a 10b5-1 plan are considered compliant with insider trading rules.

10b5-1 plans are confidential; pertain to an individual’s personal investment strategy; and do not reflect any current commentary or projections on the Company.

-Jacob Goldberger, CG Capital

1bordersooner
Posts: 17
Joined: Thu Jul 26, 2018 5:52 pm

Re: Do NOT sell

Post by 1bordersooner » Tue Aug 28, 2018 12:04 am

Excellent comments and observations by everyone. Thanks

phil
Posts: 16
Joined: Wed Dec 09, 2015 2:53 pm

Re: Do NOT sell

Post by phil » Thu Sep 13, 2018 11:20 pm

So, I just had to post. Can't believe I didn't trade a single share all day, but still long and strong. There was simply was too much excitement on SA and too much optimism, and too many demanding the answer for today, something JNJ never promised would happen today. It's actually impressive we didn't sell off more.

Look again at the tea leaves, actually more than leaves, these are facts.
The job postings in Eu regarding pricing - on the Janssen website- Posting(S!) plural, you think they made multiple errors? The Eu will get first approval, probably in MF.
New IT guy for Geron to migrate data systems. Why? obvious...
Compassionate use - on the Janssen website. Are you seriously thinking they are going to place that ON THEIR WEBSITE if not going to offer it to patients? Phone operator at Janssen, "Oh you are dying and want our drug? Sorry, we aren't going to give it to you. We were just kidding when we offered that on our website to dying patients, Sucker!..." Really?

The updated Geron presentation, which specifically notes that after a continuation decision, Janssen is doing both MF and MDS P3s and immediately after, AML P2/P3, not to mention future ADDITIONAL indications. You don't post that if not planned and ready. I am guessing they have new pre-clinical data supporting AML therapy.

Why didn't Janssen discuss imet? They can't.

These two (Janssen and Geron) are working out final details of their arrangement. Buyout or not, they are going in this big time. Again from Geron's deck, Imet targets and suppresses the Malignant Progenitor clone in MYELOID malignancies.
MYELOfibrosis MF,
MYELOdysplastic syndrom MDS,
Acute MYELOgenous Leukemia AML,
Multiple Myeloma

I'm holding on...
Phil
Last edited by phil on Thu Sep 27, 2018 4:49 am, edited 1 time in total.

biopearl123
Posts: 223
Joined: Fri Jul 20, 2018 5:13 pm

Re: Do NOT sell

Post by biopearl123 » Fri Sep 14, 2018 4:40 pm

Great post Phil, many here would agree and for those who don’t, please post opposing views for discussion. Also note MF study update on CT site. bp

Gwikley
Posts: 35
Joined: Thu Aug 30, 2018 9:05 pm

Re: Do NOT sell

Post by Gwikley » Fri Sep 14, 2018 5:39 pm

The science and the cost to pursue it ,unfortunately, will always be intertwined. In my unrealistic, and idealized world wish it weren't so. Enthusiasm about progressive discoveries immediately get translated into dollars and cents. It really kind of distorts the beauty and (allow me: magic) of the whole phenomena that is occurring around this new drug. But, I wax silly. It is what it is....lol

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