ImetelChat

Hi Ryan, yes my prognostications were meant to be overly optimistic to counter the prevailing gloom, yet they are not impossible. But that's what New Years prognostications are about--an optimistic future. Your point about the canary in the coal mine is well taken. It certainly seems that some last ...

Gwickly, I asked the two posters I respect the most to comment on your question. I just heard from the second poster. Both are posters I trust and value. Here is the second response: ""Patent protection affords the patent owner the legal right to restrict others from being able to make, use, or sell...

Gwikley, have heard back privately from a poster for whom I have a great deal of respect, here is his response: "Anyone can file a patent application claiming "my drug can be used in combination with another drug." However, getting that application approved requires the filer to prove the combinatio...

Gwikley, I have passed your question on to some knowledgeable and respected posters who might help with the answer. bp

For breakthrough therapy designation a drug must show significant advantages over existing therapy in one clinical end point. True for MF--longevity. True for MDS--high transfusion burden patients showing marked dramatic HI. Communication with FDA--for MDS (secret) non discussible but clearly ongoin...

Technically, this is a "comparator arm" not a control arm in the strict sense of treatment vs. no treatment but I do agree that the FDA should be able to use this information in a favorable manner. bp

https://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf At issue is whether the FDA will consider the MF study "randomized". Clearly they should since there are two arms. Since good old Janssen closed the study early (I thought that was a great sign then as I thought there was a strong signal an...

Kara, to your point about Geron's role in oversight of the agreement with Janssen, take a look at the 2016 letter to stockholders. I tried to copy it here but just got gibberish. It emphasizes Geron's role in planning and oversight. There is no way they could not have known about the plans for compa...

Hunt, thank you for pointing this out to me. Pt number 2 appears as a "space" e.g. zero change. I missed that since there was no bar either way. bp

Kara, I meant to suggest that it might also be worthwhile to ask about the listing of Imetelstat for patients who. were too ill for induction therapies in AML. Including this on Janssen's list of this potential indications was also incredibly misleading and pointed toward the CD. Thanks again to you...

Yup looks like we are back up thanks for checking

biopearl Comments1039 | Following If I am reading Dr. Steensma’s slides right, (slide 9), EVERYONE (except one) had a transfusion reduction. 9 had a less than 4 unit reduction but is three units no response? Many went down by three, some by two and one by one. Only ONE patients tx requirement went u...

Hunt and Kara, thank you for taking this on. I think a respectful well written letter as you are fashioning together would be greatly appreciated by many including myself. Perhaps you may be willing to converse privately via SA or if I have your permission I can supply your registered email address ...

I think it’s a good letter but I would suggest taking out the line about resigning. I do think Dr Scarlett takes his job seriously and he already knows he has a responsibility to his shareholders and will have to answer to us. I also think we know more about why Janssen walked and I agree they and G...

I don't know if too many readers are left on this board after the meltdown but it is pretty clear things continue to move in a direction that may be favorable to Imetelstat approval:

https://www.medpagetoday.com/publicheal ... ials/77038

BurtonLee, I would like to respond to your comment but might need a little help with some clarification. I do not understand "swertres" and suspect some spell correct changed what you had intended to say. I will say that your hope for a JNJ opt in decision is likely to be overly optimistic. It looks...

Hunt, I re read your post of Sept 28th and see that I did not respond. Thank you for your kind words. I very much would like to keep this forum alive and continue to hope that Imetelstat will move forward as we hope. The small community here will continue to provide a safe place to share thoughts wi...

They should be for this irresponsible behavior but I doubt anyone could climb the Janssen wall of lawyers who would just plead innocent error.