Jack Allen

Analyst covering the pharmaceutical and healthcare industry. Views expressed are my own and not recommendations.

[Jack Allen @JohnK_Allen]

Please take a minute to listen to our FREE @Datamonitor_HC Analyst Podcast published biweekly
https://t.co/xORPyXnaGN

[Zachary McLellan @biotechzm]

Check out our new DMHC Analyst Podcast where we discuss:
- #Yescarta and #Kymriah reach the EU, but challenges remain ( $GILD $NVS ) - 0:42
- #Xerava approval for intra-abdominal infections ( $TTPH $MRK $AGN ) – 13:13
https://t.co/1Cmzsfx5AK

[Jack Allen @JohnK_Allen]

$PTLA keeps their word with respect to submitting for approval of the critical gen 2 manufacturing process, now eyes turn to CEO appointment

[zach @zbiotech]

*PTLA SUBMITS PRIOR APPROVAL SUPPLEMENT TO U.S. FDA

[Jack Allen @JohnK_Allen]

Today is the last day in August if $PTLA is going to file for approval if gen 2 manufacturing, let’s see if they hit their deadline

[Jack Allen @JohnK_Allen]

For a bit of context and prior analysis around the $AKCA $IONS CRL please consider giving this free podcast a listen it was recorded in May after the advisory committee, I was joined by ⁦@Datamonitor_ZM⁩ and ⁦@Datamonitor_CF⁩ https://t.co/IewyL3H7qh

[Jack Allen @JohnK_Allen]

@joeMN1858 It’s unfortunate the medication wasn’t found to be safe, but that is the difficult job of the regulators

[Jack Allen @JohnK_Allen]

I had mentioned this was far from a lock months ago during ad comm $AKCA $IONS

Though it is tough to see this denial after such moving patient testimonials

[Andy Biotech @AndyBiotech]

$AKCA $IONS CRL suggests FDA has serious concerns on safety with antisense oligonucleotide drugs as highlighted in AdCom BD

The more important question now is what will happen to Inotersen review esp given the fatal intracranial hemorrhage case

[Brad Loncar @bradloncar]

CAR-T is approved in Europe. 🎉

Both pediatric ALL and adult r/r DLBCL approved at the same time.

[Jack Allen @JohnK_Allen]

@maninthedeep @AndyBiotech No problem, how do you expect it to move?

[Jack Allen @JohnK_Allen]

@ByMadeleineA Correct me if I’m wrong...but I think the 2024 drop is patent overhang

[Andy Biotech @AndyBiotech]

$JNJ Xarelto MARINER fails --> $PTLA finally taking a break

https://t.co/K89rPKiwID

[Jack Allen @JohnK_Allen]

New episode of FREE DMHC podcast:
-Is the FDA getting PD-1 fatigue? $BMY $MRK $AZN $RHHBY $REGN-0:41
-Preview of MARINER trial readout $JNJ $BAYR $PTLA-7:12
-Opdivo approval in SCLC-15:00
- $NOVO acquisition of Ziylo-19:54
-Approval of Lenvima in HCC-28:33
https://t.co/cTyWnbJZVQ

[Jack Allen @JohnK_Allen]

@Lblegend33 @trinh_pham13 Yea there not doing to hot right now

[Jack Allen @JohnK_Allen]

Based on remarks made by $PFNX on their CC officials are confident based on prior discussions with regulators PF708 will be viewed as equivalent to Forteo $LLY

With respect to pricing, expect it to be in line with Tymlos $RDUS at about a 40% discount to Forteo

[Jack Allen @JohnK_Allen]

@ByMadeleineA @Vantageanalysis to clarify these are all risk adjusted valuations? Do you have information on the average risk being assigned to the medications?

[Jack Allen @JohnK_Allen]

@ByMadeleineA @danboisekim1 @Vantageanalysis Any idea what you would estimate the NPV of inclisiran or the other PCSK9 inhibitors (Repatha and Praluent) to be?....would have thought it would make the list

[Andy Biotech @AndyBiotech]

Here we go... $CVS $UNH

Ohio Medicaid firing PBMs due to "spread pricing" that cost taxpayers >$200 millions

https://t.co/1DhaKlo349

[Jack Allen @JohnK_Allen]

Could make ICER and US FDA (breakthrough) significantly more powerful, assuming people take to these plans

$CVS

[Andy Biotech @AndyBiotech]

Whoa, $CVS is launching a new program that allows clients to exclude any drug launched at a price of greater than $100,000 per QALY based on ICER analyses.

That threshold would include lots of new drugs... -> $IBB $XBI
https://t.co/VWYc6W5c9e

[Jack Allen @JohnK_Allen]

@chiragontwtr What is your problem? Happy to do my best to help, please feel free to reach out

[Jack Allen @JohnK_Allen]

@OptionsGunner1 Yes I am speculating, just throwing a thought out there

[Jack Allen @JohnK_Allen]

Just sitting back and digesting the $PTLA call a bit more, could Bill Lis have been forced into retirement due to the abysmal Q2 numbers (specifically for Bevyxxa)?

I would imagine the preliminary numbers would have been ready internally rather quickly (AKA early June)

[Jack Allen @JohnK_Allen]

$PTLA reports 2.2M in Andexxa sales and 33K in Bevyxxa sales (down from 0.6M in Q1), far from encouraging numbers

Also announced appointment of chief HR officer, but no word on CEO replacement

Generation 2 manufacturing submission is expected by end of August