Best New Year Wishes to all from bp (123)

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biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Best New Year Wishes to all from bp (123)

Post by biopearl123 » Tue Jan 08, 2019 6:04 pm

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 ongoing per the benefits of fast track, we have no idea of when they meet or what they discuss but JS does and he is moving ahead. For MF--first quarter FDA exposure to data and experts. Unstated goals for this year--1. breakthrough designation in both indications. 2. Partner for European program (stated). 3. Improve value to potential acquirers. 4. Publicize longer term data in both MF and MDS studies--these studies continue and have potential to allow for longer term safety data and confirm durability of response, allow for more 8 week and 24 week TI's that will be presented probably at EHA. Its the New Year right? Time for predictions: 1. Breakthrough in both indications. 2. Modification of PIII MDS protocol and AA grant. 3. European partner of value, not like worthless Janssen (AKA oh, we made a clerical error...) 4. Confirmation of durable MDS data. 5. True OS assessment in MF with provisional approval on condition of a PIII. 6. Award EMA prime status. Happy New Year to all. bp

huntingonthebluffs
Posts: 246
Joined: Wed Feb 24, 2016 12:00 am

Re: Best New Year Wishes to all from bp (123)

Post by huntingonthebluffs » Tue Jan 08, 2019 9:37 pm

Happy New Year biopearl, a great post to start the year! I agree with your predictions and don't think anyone could say it better. Thanks for all your contributions to this web site and the Imetelstat endeavor!

bucbeard
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Joined: Wed Jul 25, 2018 12:30 am

Re: Best New Year Wishes to all from bp (123)

Post by bucbeard » Wed Jan 09, 2019 5:00 am

I second that, thank you BP!

karagozoglu12345
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Joined: Wed Oct 03, 2018 12:48 am

Re: Best New Year Wishes to all from bp (123)

Post by karagozoglu12345 » Thu Jan 10, 2019 11:21 pm

Biopearl: Thank you for spelling out the likely outcomes which will make it a great year for us longs, as well as patients. These astute predictions imply a good bit of news flow in the course of the year toward increasingly higher share price as well. My take is JS is more inclined to sell the company than to forge a partnership after the J&J fiasco, and from the suitor's vantage point there is more to Imet than MF and MDS indications and deep pockets can also exploit combos and solids. Also, it may be more efficient to run the trials and explore further indications if the asset is fully owned.

Ryan
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Re: Best New Year Wishes to all from bp (123)

Post by Ryan » Sun Jan 13, 2019 2:57 am

I'd say these are aggressive prognostications albeit reachable in theory. Approval for TN (Triple-Negative) patients in MF should happen now if not sooner.

The key to you post is the parenthetical about Janssen's 'clerical error'. This would be an error by perhaps a half-dozen or more trained professionals en route to being publicly listed on their website. And this I would believe to be the canary in the coalmine that good things are to come for Imetelstat broadly, and if nothing else we should see concrete signs of progress in 2019 of these "coming good things"

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

Re: Best New Year Wishes to all from bp (123)

Post by biopearl123 » Sun Jan 13, 2019 3:28 am

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 minute decisions derailed the CD. The shame is that Janssen and Geron covered it up with the so called clerical error explanation. The result is a full eight or nine months of delay in the initiation of the MDS study and a loss of faith in the stock, the company and its management. As you know TN MF patients are about 5% of the total MF population and approval for this indication alone would be a pyrrhic victory. We can agree that MOS for all mutational groups was remarkable and support approval. I hope the FDA sees it that way and their guidance re OS as the ultimate approval signal suggests they will. Now we have to deal with the government shut down and I suspect we may hear of more delays as a result. But yes many people had to be involved with the plan as it appeared to be moving forward suggesting a close decision, nonetheless it was handled in a brutal and misleading way, one which I am not forgiving about and one that warranted a more detailed and honest explanation, especially if we are to trust and support our company leadership. bp

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