would not even compare to last year's CRL to Merck Suggamaddix (that was only 2nd CRL) and to a well established huge biotech - clearly they have another chance plus approval in other countries.
3rd CRL to Mannkind however would ruin the company's chances and vaporize many investments dreams and hopes for the betterment of mankind no pun intended.
if mnkd is rejected it's because
1. they used a different dosing algorithm for the affinity trials and now want an algorithm that wasn't used in those trials = poor mgmt. decision
2. no data to counter fda's findings of non-proportional efficacy at higher doses = poor mgmt. preparation
3. in 171 basal wasn't titrated equally across arms
4. in 171 SC wasn't properly titrated to maximize its effects. had it been, TI wouldn't have shown non-inferiority. iow, mnkd rigged the game in their favor and fda knows it.
5. they're still po'd that mnkd lied about their interaction w/ fda leading up to the 2nd submission and it's data/trial designs
6. BG levels weren't captured at equal times for Afrezza vs comparator. again, mgmt. attempting to rig the game
7. the amount of rescue therapy needed w/ Afrezza given it's titratable
8. 171 showed it was statistically non-inferior but numerically, without question completely inferior
9. fda questioning whether 171's results were the result of higher basal titration rather than afrezza's effects. this includes the comparably better hypo results for Afrezza.
10. a1c is the fda's recognized metric of a diabetes drug's effectiveness. in 171 those below 7% and 6.5% heavily favors the comparator. (almost 100% for the 7% threshold and nearly 50% for the 6.5% threshold)
11. existing data doesn't address whether long-term treatment w/ Afrezza may promote or enhance pre-malignant bronchial and/or lung lesions
on a sidenote....very interesting that al's boasting about 1 participant being responsible for nearly half the hypo's mysteriously was never mentioned in the adcom; not even hinted. more al bs!
know what you own. know the risks. ignore the pumpers and READ THE DOCUMENTS. this isn't a layup.
you better understand the risks.
you may now return to your pumping....
you are highlighting the exact issues that the Advisory committee just reviewed and voted overwhelmingly to approve. Now, granted, your points could weigh heavily against Afrezza's FDA approval. I doubt there is a perfect insulin study with the comparator limitations as we have discussed before between inhaled (ultra-rapid) vs SC RAA. However if the FDA completely ignores an overwhelmingly approved panel vote because of factors such as (stat vs numeric NI, conversion ratios, unproven promotion of lung cancer, etc..) then how can you explain the purpose of the Advisory panel in the first place?
Please post your opinions as to why the Advisory panel is not worth it's review?
Ketoacidosis breath, I cannot refute your claims as I did not witness the AdCom. But I do believe you are reaching with many of you conclusions.
1. You state. "They used a different algorithm and now want an algorithm that wasn't used"? So now they have settled on their third choice? Highly unlikely.
8. "171 was statistically non-inferior but numerically inferior"? Come on you can do better than a play on words.
11. "Enhanced pre-malignant bronchial and/or lung lesions". First I have heard about this. Like I said, reaching.
Sentiment: Strong Buy
Anybody with expertise care to refute some of the above points. I am sure FDA fully expected not to approve Afrezza based on their concerns and only needed two weeks to put that decision to paper. Now, with so much more to sift through, the FDA needs more time to reconsider OR more time to help solidify its reasoning for non-approval after the positive ADCOM vote. I wonder if they still have every intention of keeping Afrezza from reaching the public and why?
How was all of this missed at the Adcom? Are you saying the Acom panel's vote was not based on the FDA's notes. Do you think the presenters were wax figures. Those were real people with real experiences using Afrezza. it seems your list is taking some liberties with the truth to say the least.
oppie, you are really lost! and you've lost so much money here you don't know what to do. lol. too funny. your list above is all B.S.. you sound a lot like adam feuerstein as he bashed vnda's trial designs during adcom. the fda approved vnda because they helped change the trial points. similar here.....trial design was fine. even Matt said mnkd would probably be ext pdufa.....no surprise. your just going to have to wait :) i suggest you go borrow some money. nothing is going to happen until July. you'll have time to cover on the options you're losing on and go long. look for a buy between $3.75-4.75.JMHO
if it gets rejected that means all those 27 out of 28 members of the advisory committee were either idiots or they were all in to manipulated the share price of mankind, and make money out of it.
It would definitely be the scandal of a century