MSB - a new dawn, page-1993

" Dr Vijay Kumar has the advantage to be promoted by another Indian, Dr Prasad."

Nope.

Dr Vinayak Kashyap Prasad is of course an American, born & raised in Euclid (an inner suburb of Cleveland) Ohio. Then he went to school & college there i.e. America, USA.

So your assertion that he's nonetheless 'Indian' must be based on oh-I-don't-know his name maybe, or perhaps his skin colour or the 'funny way he speaks'. Any way you slice it, it makes for some pretty damningly good evidence that you're comment came out as an objectively racist comment - i.e. despite your intent to 'stress' to the contrary. Woops.

BTW you must understand that the apparent racist bias also destroys any compelling logic in what you posted earlier. I tried to get around it, but sadly had to admit that it rips the underpinnings out of your own argument. Yikes.

My point? Perhaps rather than have MSB 'appoint a director of Indian ethnicity' (yep, you did it again) you'd like to reconsider your post.

PS: If you're in any way actually interested in Dr Vijay Kumar's credentials for the post & possible reasons (other than ethnicity) why Dr Prasad may see him as having the ability to support the new Commissioner's disruptive agenda then you may care to read the transcript linked below featuring the good Doctor's own activities. As you read it, I recommend that you remember the agenda that President Trump took to the last elections, and then took to the Senate when announcing Mr Kennedy as his preferred nominee as Secretary, HHS. Note also that when asked for comment on Nicole Verdun being placed on administrative leave, HHS spokesperson Andrew Nixon apparently told Stat that,

“Center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science.”

So, maybe the need for 'support' is a factor in what's happening with Dr Verdun atm. I could speculate that what Dr Prasad is looking for is less 'Indian' and more a willingness to support aggressive targets that are intended to be disruptive of 'cozy relationships' that have been built over time. Anyone interested on the factual background can read a little more about it here: https://www.raps.org/news-and-articles/news-articles/2025/6/this-week-at-fda-fda-announces-new-drug-voucher-pr

So, here was what Dr Kumar was focussing on just before Dr Verdun was appointed:



Link here: https://www.fda.gov/media/173146/download

And in Dr Kumar's own words in 2023:

" With an increasing number of cell and gene therapy products in development and the potential for more of these products to become available to patients in the future, it is important to understand the full spectrum of long-term effects and collect accurate, timely, and comprehensive data to ensure these products remain safe, effective, and of high quality"

Yep, it's hard IMO not to immediately connect Dr Kumar's experience and credentials in 'listening to stakeholders' with exactly what the FDA Commissioner and the Director of CBER have been doing in their across America for the past 2 weeks i.e.




And you'll no doubt notice that the Agenda items that Dr Kumar was managing in the CBER OTP Listening Sessions during 2023 are exactly the same matters that Dr Prasad has been banging on about as the necessary flipside of an FDA willingness to accelerate development i.e. the need for rigorous post-approval testing of efficacy using RWE, and especially Registry materials e.g. from CIBMTR.

Gold-standard science together with common sense. That's the philosophy mantra I've been hearing from Dr Prasad & reading about in his books (especially 'Malignant' 2020, Johns Hopkins University Press) . I could interpret that soundbite easily as including accelerated development by the FDA (quick CMC turnaround, winner 'picking' with the new National PRV program) all conditioned on enforcement of efficacy demonstration post-approval i.e. OS and QoL. Something Mesoblast seems extremely well positioned to show the new Administration with REVASCOR annd RYONCIL data for 5yrs+, despite the inability to demonstrate (IMO unhelpfully spec'd) primary endpoints met with the statistical significance required for standard approval for REVASCOR, or extension of RYONCIL's label.

Sounds to me as though Dr Kumar's 'philosophy' and the vision of Drs Makary and Prasad might have aligned long before the new Administration came in. And sad though it is to see Dr Verdun on admin leave & sidelined atm, she hasn't been terminated yet & presumably hasn't resigned, so it may be that she just couldn't bring herself to immediately push the new Administration's policy requirements that aggressively.

There's a happy thought.

Cheers
GLTALTH