ImetelChat

Blind mystic Baba Vanga's predictions for 2021 =====<<<<<<<<< Right before her death at the age of 85 in 1996, she said 2021 will be the year a cure for cancer is found =========== Go Imet https://www.mirror.co.uk/news/weird-news/blind-mystic-baba-vangas-predictions-23210686 ===== Please excuse if i...

Front line treatment are a beast to design, execute and fund. Once a drug is approved, even if later than the front line, its use in the treatment protocol earlier than the approval is not ruled out. If I were on GERN mgmt, I would have voted for last line Rx for trials anyway. What is disappointing...

Third

BP., Totally respect your viewpoint. 9% in absolute terms ... not a good idea. I have a buisness, I know. If my returns on my work (technology services) is, say, 10% returns, then paying 9% to bank = very bad idea. Of course, if the need is only temporary and short term, I may compromise. However, i...

To the statisticians who have analyzed the results... any chance that we may see clinically relevant and statistically significant results sooner? If the study was overpowered to actually have a significantly powered interim analysis... would that be a driver for recent fund raising?

Hypothesis welcome!

So in other words, simply put, CD 47 is less a threat to Imetelstat. But, due to the potentially disease modifying effects, Imetelstat is a commercial threat to CD47.
IF this is the case, seems that GERN would be an acquisition target by GILEAD. Ummmm...

having worked on launch planning for oncology drugs in my previous life, Sales & Marketing can be typically involved even at the P3 planning stages...especially when there is a need to support marketing claims through data analysis (and therefore, need the information at the statistical plans which ...

"Kmall, your not so good news scenario might not be so bad. We know for sure the FDA is not going to approve until they see PIII data. (Their recommendation for yet another low dose arm in the MF study is infuriating and suggests they haven't been paying attention.)" [/i] Another theory - please re...

A wild thought. Given the "brighter" regulatory prospect in Europe, would it not make better value for shareholder (better negotiation position) to defer the formal EU partner selection till a Marketing Application in EU is filed? Or at least further along the process versus announcing the EU partne...

Kmall, first, I am a fan of your postings, and a genuine "gern bull" i.e. against my better judgement (for now), I was ALL IN on GERN before the CD with J&J. So I am sitting on a significant paper losses, and my next few comments are with utmost sincere sentiments. In highlighting Damanjit's linkedI...

Interesting.
So not only do they cover multiple disease ares (low risk and high risk) ... but also different modalities/pathways !
Just brilliant!

Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS)

https://www.businesswire.com/news/home/ ... esignation

For those of us, who are not as savy in reading the detailed document or ... for those who want a "cliff notes"/summary version of the interesting element ... What is/may be the working hypothesis? Clearly, given that this forum is not an official board of the company...no need to worry about the sa...

BP,
Thank you as always for thoughtful response.
One more follow up. What is the requirement for a +ve MDS Orphan Status in EU?
A question arises, why now, versus earlier or later?

Likely Avastin like platform is what dreamers can dream about.
Not doubt, JS, a few years ago, "misspoke" about Genentech as a potential partner vs. J&J.

Question for the regulatory experts. The limited use of the RWD by the US FDA seems to not be as scientific. Either allow the use or don't, but to say it cannot be used for 1st induction makes it more arbitrary than scientific. Or have constraints that the use of RWD for approval will be tied to saf...

ok... silly question or clarification.
What do you mean by "due for a break"?
What is your hypothesis?

Ok... I am an amateur with respect to regulatory affairs, but did pay my dues at the periphery supporting drug development from a program management standpoint. Question for the clinical/regulatory experts. Data Point #1: IF – per AGIO press release the following is true – “ AGIO announced that the ...

"the best way to predict the future is to create it" - Peter Drucker. My favorite Management Guru!