Secrecy concerning the present clinical trials

[sargasso]

This is no doubt a dumb question. But I will ask it anyway. It’s my understanding that imetelstat acts quickly. It seems to me, therefore, before too much longer GERN/Janssen/JNJ will obtain some idea of how patients are responding to the drug in the present clinical trials. But the results of those trials will not be made public at any time in the near future. What is the reason for this secrecy and why is it deemed necessary?

[Fishermangents]

Sargasso, I don't think that this is something exceptional in business, certainly not in big business like this. At least, I am not the slightest bit of surprised about it. In my view there are various reasons:
- imtelstat is a new drug, with a new MoA, in a very complex area of human biology. It is better to see as much data as possible, trying to understand and interpret them, instead of going out too early with interpretations that may not prove to be accurate later on. They are professionals and they know what is at stake.
- As you can read in the latest 10-K, every opprtunity is taken by certain people to bring Geron and its management to court. Either to try to make some money, or to slow down or even kill the company. Also here it is better to say nothing, until things are pretty sure.
- If imetelstat is as transformative as JnJ and Geron are saying, the stakes are enormous and beyond our comprehension. That means competition needs to be kept in the dark as much as possible. Yes, Geron has a lot of valuable patents. But if competition knows what your are doing, they can work things out in order to circumvent the patents or maybe deliberately challenge them. In addition it says in the 10-K that a lot of Geron's IP is based on trade secrets. That's another reason to be very carefull.
- (almost) everything depends on a healthy and trustfull relationship between JnJ and Geron. Certainly Geron will not put that at risk by speaking out loud, while JnJ prefers silence. All press releases on IMbark and IMerge came from Geron. Have you noticed that?

So there you have it:
- complexity of the biology and MoA of a new drug which needs to be understood
- prevent legal problems and claims
- keeping competition in the dark
- protecting JnJ - Geron relationship

That's my take and I can live with that. I would advice you not to go into the paranoia we continously see at some other message board.

[sargasso]

<< I would advice you not to go into the paranoia we continously see at some other message board. >>

Your comments make sense to me and are appreciated. But I don’t think my question indicates I’m going into paranoia. I’m not interested in paranoia or unreasonable fear. Rather I think I’m asking a legitimate question as a GERN shareholder. As an investor I wish to receive as much information about this drug as possible. That is my responsibility as an investor and as someone who is backing the company by means of a substantial investment. In return I wish the company to share information with me when it is possible to do so. That is the implied deal I am making with the company and that is why the law insists upon disclosure to shareholders of material information.

It may also be worth noting that it’s not uncommon to release Phase II results. Here’s an example. I selected this at random. One could select other examples. It seems to me the release of such data is important:

“On Thursday Feb 18th in after-hours trade, shares of Athersys (NASDAQ:ATHX) were up 21% after the company announced positive phase 2 results for its Stroke trial. The phase 2 trial had two different parts. One part had a small dose selection phase of 16 patients in two cohorts, and the other part had 118 patients in the efficacy phase.

Patients were either given Athersys’ Multi-stem cell therapy intravenously or received a placebo compound instead. The trial recruited patients with a type of stroke known as Ischemic stroke — obstruction of blood going to the brain causing damage. This data presented today was a one-year followup of these patients who had improved in outcome…..”

http://www.biotechpicklist.com/athersys ... e-results/

[biopearl]

Sargasso, what is it that you want exactly? The company has released data via the NEJM supporting very important and new responses in major hematologic malignancies. The basic science data e.g. the heretofore discussed AACR abstracts confirm Dr. Lane's amazing mouse studies and show to further AMAZING reductions in viable AML cell lines not to my knowlege previously reported. The black out is what has happened beyond those studies, i.e what is the longevity data from the Mayo study. Can any statement be made re prolongation of life? Why only four weeks of data in the latest Janssen AACR offering etc. The reasons go to Fisher's points. This company and its partnership with Janssen are a class act. No self aggrandaziment to artificially raise the share price. When it comes it will be self evident. The data to my read is already there. People are looking through it not at it. Complete reversal of bone marrow fibrosis? Unprecedented? Well what is it that you want? The road to approval is tortuous and loaded with legal land mines. Janssen/Geron has no reason to rush and make a mistake (Janssen knows the regulatory landscape well). They have no reason for unreasonable delay either. I have held this stock for over fifteen years (at least), through all the breast and lung studies and the disappointments and pain. Don't expect anything. They will release information when they are ready. If you don't believe this is a transformative agent (Janssen's words from a world class company that may corner the market on heme malignancy treatment), then perhaps nothing will convince you and you should think about investing in a "safer" environment. Good luck, bp

[sargasso]

<< Sargasso, what is it that you want exactly? >>

What do I want? What I really want? I want GERN to tell me in no uncertain terms that I will make a fortune off the stock. That's what I want. <grin>

[biopearl]

Ditto that.

[Fishermangents]

Sargasso: the paranoia remark was not personal. Sorry if a made that impression. Investing in early biotech just asks for strong nerves and a steady course. Read the signs and make up your (own) mind... Since the JnJ partnership all the signs have been consistent. I bought during the hold, because of what Tefferi said. That was my sign that time, and he still is. Only now supported by the biggest pharma on the globe.

Bio: 15 years in Geron! Respect, man. Yo, you must have seen a lot.... Must be difficult not letting the past chasing you. Appreciate your positive attitude. I think Geron is a completely different company now. Much more focus and a strong dynamic towards commercialization. And with JnJ as a partner.

[biopearl]

Thanks Fish, good thing I live in the great plains. (No cliffs to jump off of.)

[sargasso]

Fisher,

I understand what you are saying. Both you and biopearl have made valid points and I appreciate your insight. In order to avoid any confusion I should perhaps observe that I have no desire to sell GERN. In fact, it is by far the most interesting stock I own.