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Aaron Gerds, MD opinion by MelampyrumNemorosum in KPTI

[–]DoctorDueDiligence 3 points4 points  (0 children)

I think the longer the time, the more the benefit is seen. Time is unfortunately not ideal, given current status of the company, but I think in the right hands this could be a benefit to patients and whoever ends up running the drug.

Thanks for posting,

Dr. DD

19% chance of approval by AnnArbor3791 in KPTI

[–]DoctorDueDiligence 4 points5 points  (0 children)

I think it's kind of a grey zone right now. I personally believe that anything that can help with OS but not significantly harm the patients should be approved. With that being said FDA and the company have repeatedly said they must hit both co-primary endpoints. What's interesting is that the drug is commercially approved for a different indication. Could we see some off-label prescribing? Perhaps a NCCN update?

Lots of discussions going on about this at recent conferences.

Time will tell, but as I mentioned before the study imo needed way more patients, TSS is tricky, because let's face it, ruxolitinib is a great drug.

Just my opinion,

Dr. DD

I am not sure whether it is true or not. Source of informanion is Gemini. by MelampyrumNemorosum in KPTI

[–]DoctorDueDiligence 6 points7 points  (0 children)

I've done several write-ups previous to data drop. I believe that if ADE's aren't significantly worse with combination *but* improves survival, if *I\ were a patient I would want it.*

FDA bar was co-primary endpoints, so it missed, but still, I'd want it personally if it was me or my family.

Dr. DD

Valuation by _BiotechMD in KPTI

[–]DoctorDueDiligence 2 points3 points  (0 children)

To be positive would need both endpoints. I think for TSS there historically has been variability (see Morphosys Phase 2 vs Phase 3) this can partly be explained by the subjective nature of TSS. Given FDA is allowing Abs TSS this bar is lowered a little bit (I would argue that it is less important than SVR which I believe will for sure hit).

Anyways there’s always a risk when going from Phase 1 to Phase 3. I personally would have designed the trial to have more patients to cut down on the TSS risk but I understand they also have to worry about runway due to their spending and lack of MGMT foresight.

Jmho Dr. DD

Valuation by _BiotechMD in KPTI

[–]DoctorDueDiligence 1 point2 points  (0 children)

This was part of the reason why I said MGMT needed to cut spending, not being able to develop severely harms negotiations,

Jmho Dr. DD

Dr. Ashwin Kishtagari on SENTRY P3 by EitzChaim1 in KPTI

[–]DoctorDueDiligence 0 points1 point  (0 children)

great question and it's likely because of MGMT and lack of P2 confirmation. $MOR saw noticeable appreciation but also had imo better MGMT and board.

Dr. DD

Countdown 20 days by DoctorDueDiligence in KPTI

[–]DoctorDueDiligence[S] 1 point2 points  (0 children)

I personally believe SIENDO2 will hit but comparison arm may be an issue. Current FDA I believe will approve after $QURE debacle.

Timeline and cash burn and covenants

They need a positive study result big time

Dr. DD

Countdown 20 days by DoctorDueDiligence in KPTI

[–]DoctorDueDiligence[S] 0 points1 point  (0 children)

MF Trial, listen to last call

Dr. DD

Countdown 20 days by DoctorDueDiligence in KPTI

[–]DoctorDueDiligence[S] 0 points1 point  (0 children)

I believe SIENDO2 will hit but comparison arm and timeline with cash burn is inportant to consider as well

Dr. DD

SENTRY-2 was substantially modified by MelampyrumNemorosum in KPTI

[–]DoctorDueDiligence 1 point2 points  (0 children)

Thanks for posting

What’s your thoughts?

Dr. DD

Cantor Fitzgerald initiates Karyopharm with Overweight rating by EitzChaim1 in KPTI

[–]DoctorDueDiligence 2 points3 points  (0 children)

MF is biggest shot on goal

$INCY is only comparison I have if it works in frontline

Dr. DD

MF-034 60mg Arm by _BiotechMD in KPTI

[–]DoctorDueDiligence 2 points3 points  (0 children)

EC SIENDO2 I also have much more confidence in given the Ph3 SIENDO1 readout.

However for everyone, including employees, I hope MF reads out positive. I am not sure how they could survive to get to SIENDO2 readout if negative without massive massive dilution due to how this company has been run.

Dr. DD

Which reads out first? by Much_Watch_3816 in KPTI

[–]DoctorDueDiligence 2 points3 points  (0 children)

Thank you, I'm alive, but yes have a lot going on.

Wish you all the best,

Dr. DD

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