Daphner Linve

@Master_SeaSeo Your biggest problem is that you get ahead of yourself. I know you're eager, and I respect that but you need to stay grounded and always keep your guard up.

1/2 I expect The smoking gun for $QURE Accelerated Approval (AA) is hidden in plain sight. 🚨 ​The new "VP of Advertising" job requires expertise in "Subpart H" and "FDA via 2253". $qure

@GavMcCracken Looking at the current market, oil prices are likely to fall further from here.

Exxon obviously have no clue what they're talking about. Why on earth would a core company in the oil supply chain know anything about how f*cked the oil supply is?

@UndervaluedOnG Looking at the current market, oil prices are likely to fall further from here.

Latest comparative inventory analysis using EIA data through 5/28. WTI fair value calculated at $95, or ~$5 undervalued from current market price. 11 month low in commercial petroleum stocks (ex. other oils).

@AB1001_disciple What's the point of all this? In the end, it doesn't even get approved

@AppleHelix You know what? Prasad He's not working at all, just tweeting all day. What a fucking loser.

"Excellent" that CBER research should be approved by a single person whose has never gotten an NIH grant. Neither Prasad nor Mandrola has ever obtained a NIH grant, and they probably haven’t held a pipette since their college biology lab.

@RNAiAnalyst Vinay Prasad, the same guy who swore yesterday that Pazdur running CDER would be the death of the FDA, is now out here retweeting praise like a good little boy. Nothing folds faster than a ‘principled’ critic when the White House actually turns up the heat. Pathetic

#FDA first Makary posting of wrong newspapers were in suggesting that Pazdur would never agree to head CDER, now Prasad retweeting praise of him. This shows they are feeling the public pressure, probably via the White House. The FDA needs fresh ideas from the outside, but not from the narcissists currently running it.

@biosleuth It's finally been proven Frasad really is petty. Whenever he retweets something favorable to himself, he scurries around like a rat

So Vinay has logged back into twitter for the first time since May, simply to RT the one guy who praised his letter. Truly amazing.

@DrDeepMD @VPrasadMDMPH @MartyMakary Even just having the mentality to pick out good takes and retweet them is impressive.Yeah, he’s definitely an idiot

My only criticism: he obviously should have used “buckets” instead of “baskets” But otherwise, this is probably one of the clearest, most level headed, honest, and mission-oriented notes I’ve seen from a govt agency leader True leadership is hard @VPrasadMDMPH @MartyMakary

@canoebrookbl Your only flaw is that you get overly dramatic

a buyout might be imminent as $qure’s last legal advisor Ropes and Gray all of sudden published two cell and gene related FDA reviews in a month (in two years)! premium might be low at around $100 (50% of pre-Nov. 3rd) as $qure has a preferred bidder similar to PFE/BHVN situation

@anish_koka “That’s fucking bullshit.”

Tax payers should hope Vinay Prasad has a very long tenure at the FDA.

@DrMakaryFDA Aren't you terrified that your actions are causing rare disease patients to die?

Today we’re announcing a “meeting minute clarification opportunity” which gives companies an opportunity to get a quick post-meeting clarification within just 3 days. fda.gov/news-events/pr…

We’re increasing communications with sponsors.

@canoebrookbl bullshit As long as Vinai is there approval will be difficult

Normally no but the tone could be different. I was with a bigger biotech whose FDA meeting debriefings were constantly more optimistic than the actual meeting minutes. But normally the tone could be different but conclusion is similar.

@hawkking1515 Realistically, uniqure has only one option left now

I bought a bit more $QURE today. I hope Matt Kapusta proves his capability at the conference call on Monday.

@RyanFinTwit @AB1001_disciple In fact, the chances are basically zero because of those two idiots at the FDA

@AB1001_disciple This kind of sentiment-driven pessimism pops up whenever the $CLPT share price goes down. Not considering the rest of the ClearPoint partners, even $QURE alone has AMT-260 in the pipeline and the non-zero (to put it conservatively) potential of an FDA reversal on AMT-130.

@mickeychiku there’s no point in that now

$Qure call tomorrow. Some good questions to ask for those attending: 1) Are you confident that your trial design met comparability, sites, patient characteristics, missing data, timing bias, measurement method, and statistical analysis as outlined in FDA’s Feb 2023 guidance - fda.gov/media/164960/d…? Which particular area FDA has the most concern? 2) If your study design was already finalized prior to release of above guidance, did you perform retrospective risk analysis and consult agency for any gap in your ongoing study and potential grace period to comply? 3) Will you be comfortable releasing redacted prior meeting minutes? 4) Did US based regulators experienced in dealing with FDA represent you in type B meeting? Did FDA leave any room to provide further justification on gaps identified during the meeting? 5) Do you still plan to submit BLA with justification provided for all the gaps/concerns identified during the meeting? Good luck!

@Bionavgator Bullshit

$qure - why would they preannounce earnings in a rush(3day lead vs 7day) though they have enough window available before deadline.. my read through is they are meeting with FDA again this week before the formal meeting minutes.. (FDA may have requested this meeting due to outside pressure)..

@canoebrookbl Don’t talk in vague terms

$xbi, $bhvn, $qure, rumors or not?