If you are feeling anxious about the future of Imetelstat in LR MDS…

[biopearl123]

As we approach the NDA acceptance date, if you are feeling a little anxious, ask your self the following:

1. Are you aware of any agent in development or in the clinic that has shown conclusive disease modification in this condition. Answer: Yes you are.

2. Are you aware of any agent in development or in the clinic the has resulted in substantial numbers of patients going from the equivalent of 1 transfusion per week to NONE for well over a year? Answer: yes you are.

3. Are you aware of any agents in development or in the clinic that appears to return the bone marrow to normal and can raise the hemoglobin over 3.5 grams? Answer: Yes you are

4. Are you aware of any agent in development or in the clinic that is effective for both R/S+ and R/S negative patients? Answer: yes you are.

5. Are you aware of any agent in development or in the clinic that specifically attacks the malignant stem cell and malignant clone selectively? Answer:Yes you are.

6. Are you aware of studies with endpoints specifically designed to assess drug effect on longevity. Yes you are.

7. Are you aware of any agents in development or in the clinic that actually impact profound fatigue? Yes you do.

8. Are you aware of any company with a unique drug that is poised to hire over a one hundred strong sales force within the next few months? Yes you are.

So sleep well my friends. You already know the answers and so does the FDA. Regards to all, bp

[kmall]

Bp - great points on all. Many reasons to stay focused and positive as investors, despite the cacophony of noise elsewhere and constant drag on any momentum of the SP. It certainly has been a tough education with respect to patience and expectations, even for many of us who have weathered the storm of 2018, doubling down and continue treading water. With all that said, me being Kmall, I could compile a list which would be the complete opposite of yours on the actions, or as I'd like to say, the inactions of the FDA these past 5yrs or so......

1. Can you believe that despite overwhelming evidence from P2 data in both the IMerge (MDS) and IMbark (MF) - now IMpact - Clinical Trials, showing an increase of 14% or more Ti (MDS) and over DOUBLE the Overall Survival rate (MF) in these patient groups from that of any other already APPROVED therapy or BAT in competition available, that the FDA hasn't approved Imetelstat - especially given Fast Track Designation and Orphan Drug Status were both granted many years ago. Answer: NO....I can't believe it !!!

2., 3., 4., 5., 6......I could go on and on. But every statement ends the same, as the deaths and struggles of these patients continues these past 4+yrs - with NO....I can't believe it !!!!

And trust me..... there's a word in-between can't and believe, which deserves it's placement there, but due to Imetelchat forum rules I can't use it. In the meantime, I'll refer to the positivity in your post, and hope that the FDA doesn't drag this out to the nth degree. I'm certainly not holding my breath. Meanwhile patients are dying every day. Imetelstat is proven safe and overly effective for the indications targeted. Let's do this already FDA !!! - Kmall

[LWS]

bp --- One never knows for sure, and this has been a very, very slow process. I believe that every (i) has been dotted and every (t) has been crossed. The finish line is in sight, and we do not wish to collapse before we get there. The NDA is summited and under review.

An EAP (extended use and compassionate care) is now in place to cover this time-gap before formal approval. Imetelstat is unique, proven, disease modifying, and addresses blood cancer patients' unmet needs.

I believe all is good and well for acceptance and approval of the NDA.
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Previous for Review:

The NDA has become the only item of importance, at this point in time. If the NDA is accepted and approved (fast-track & orphan status in place) then all is well. If the NDA is rejected, then Geron has no alternatives to Imetelstat, and is likely finished.

Considering the successes of Imetelstat to-date, I don't see how rejection is possible. Also, the staff (Kmall's specialty) and the manufacturing preparedness would not make any sense, unless Imetelstat was very good now as a single-agent, with greater potential in combinations.

The heavy lifting is done. I see no other 'shoes that can fall' to stop Imetelstat from being approved on several levels as a single-agent medicine, that is also suitable for off-label uses. The modular NDA is under review now, with patients' needs the #1 priority. The timeline for acceptance and approvals is always the question.

[biopearl123]

Kmall, wellllll, I have no counter argument to your points. Not a one. This all should have happened a looong time ago. A long (insert word) time ago. “Fast track” is laughably euphemistic.

[LWS]

FUDD (Fear, Uncertainty, Doubt, Deception)

The EAP should mean that the NDA is close to acceptance (Aug. ??) and approval (Sep. ??). With Geron nothing is predictable.

[LWS]

Of course we are anxious:

We all believe that the FDA will accept and approve Imetelstat, especially with the EAP in place to cover any time gap between now and approval. There is always an infinitesimal chance of rejection, but it is not zero percent. That seems to have everyone on edge, along with the PPS under $3.00.

All is well that ends well