Those nasty titers could have been the downfall of HALO. That's why the share price is at the same level as 7 years ago. Now that has all changed. Onwards and upwards.
I agree Roto. So long as the post approval requirements aren't too ominous then this looks fantastic news for the whole HALO US program. I would expect a huge increase in new partners once HyQ has been approved and I would also expect Roche to commence FDA negotiations re getting SQ Herceptin and SQ Mabthera approved in the US. This now looks like a company about to fly.
Ask yourself who would be the main beneficiary if the FDA basically knocks all HALO SQ on the head today. Can anyone think of a major IV supplier who might be delighted albeit shedding crocodile tears.
But Gammagard is available to all patients now. HyQ is no better than Gammagard - just more convenient. So why take the risk if Baxter can't prove after 2 years that there isn't a risk. Can they?
So neither the FDA nor Baxter can prove their arguments that the antibodies may or may not cause problems over the life of the patient. So does the FDA give Baxter the go ahead and tell them to do a lifetime study on a set number of patients or does it reject HyQ on the grounds that there is a safer version (Gammagard) already on the market so why take the risk. The FDA is a cautious body of course.
fattlady - where did you get your information from? I can't find it on Page 14 of the briefing document that you referred to.
You just forget to mention the onerous post approval studies that Baxter will have to carry out - one up until the patients die. Enough to put off any potential new partners not to mention Pfizer or Roche? So the onus is still on Baxter to prove that titers really aren't dangerous over the lifetime of a patient. I can't remember ever seeing such an onerous set of post approval studies. Can you?
If you hadn't noticed Anui the FDA has taken an extraordinary amount of time to decide nothing on the expanded Hylenex label for Insulin. If you think this is unrelated to the HyQ case you need your head examining. Are the sister products of blood clotting PEG safe? Nobody knows is the answer. HALO can't prove their case that they are - equally the animal studies look ok. So it looks like the FDA will approve the products subject to massive post approval studies - one even for life on HyQ. Most companies would think twice about such a commitment. Pfizer and Roche may be pondering exactly that.
Fred - having waded through all 204 pages with a fine tooth comb I can now confidently predict that HyQ will be approved 15-0 by the ADCOM. It appears that the FDA are not in the slightest bit concerned about titers causing strokes. Baxter however will have to conduct numerous post approval studies - some right through to patients' deaths. It seems like the FDA are prepared to concede the point but the onus is still on Baxter to eventually prove it. This if course might put off other potential partners as presumably the same rules will apply to them too. So this is partially good news but not great news.
Aniu - I'm sure it'll all be clarified for you in the ADCOM meeting. I have an uncanny knack of being able to read between the lines. Have you never wondered about the relationship between blood clotting PEG and its sister products HyQ, SQ Cinryse and Hylenex - all of which the FDA are/have been questioning? HALO has been going through every single scrap of trial data relating to these products to try and disassociate them from PEG. Have they been successful - watch this space - because if they haven't then HyQ and then everything else is doomed.
I on the other hand was spot on with ACRX. Nobody else even mentioned that the device was completely flawed and groggy patients were spilling little blue tabs all over the floor.
So what about HyQ? Titers = blood clots or worse is the only topic of conversation. Has Baxter proved its case that they don't - definitely not. If the onus is on Baxter to do that then it's a 15-0 rejection IMHO. If the panel take the opposite approach and say OK we accept that it's unlikely so let's give HyQ the benefit of the doubt then it's a narrow win for HyQ. But does giving the benefit of the doubt sound like an FDA approach - of course not so it's a massive rejection.
Fezz says what's next. Well of course Hylenex could be withdrawn and the Pfizer program stopped and Roche will not proceed with SQ Herceptin and SQ Mabthera in the US. And you never know, the EMA may take a second look at the situation themselves.
And this all from the only guy who got ACRX correct.
Actually it was the inability of groggy non supervised post op patients to operate the machine properly - dropping little blue tabs onto the floor and causing a safety hazard. Is there any other scenario in a public hospital where self administered opioids could finish up on the floor. I don't think so. Do the FDA want Zalviso approved. It appears not. Only 15 officially reported dropped little blue tabs - but how many unreported? A whole load I'm sure. Just ask Mrs Murphy.
What can ACRX do about that? Absolutely nothing. The machine is what it is. You can't stop groggy unsupervised post-op patients from spilling their little blue tabs. Either they stick to the underside of the tongue or they don't. If they don't then they could finish up on the floor and that is a safety risk.
5 years and 2 CRL's and now they are talking about a mid year 2015 3rd attempt for Remoxy. Stability is a major Opiod problem but this Board seems to be dismissing it as a minor problem that can be solved in months. Not so. I can remember 5 years ago after the first CRL PTIE staying 'no further clinical trials'. That was true but testing slightly amended formulations for stability and bio equivalence takes years - 6 in PTIE's case.
So groggy unsupervised post-op patients self administering little blue tabs under their tongues and dropping them onto the floor, into the sheets and down their pyjamas was an issue after all. And it is a safety issue too. The only surprise is that the FDA didn't issue a straight rejection. Not much you can do about little blue tabs being dropped IMHO. The whole idea was ridiculous and is insolvable.
So why didn't the FDA just delay the PDUFA date by up to 3 months to give them time to review the amendments? This makes no sense. There must be some fairly serious issue here - little blue tabs all over the floor perhaps? Medium to high risk of user error requires human factor testing. It looks like the FDA doesn't like the machine and if that isn't fixable then it's curtains.
In the Scope of the draft guidance, FDA states that as part of their design controls, manufacturers conduct a risk analysis that includes risks associated with device use. The Agency then states the actions a manufacturer should take following the results of the risk analysis:
“If the results of this analysis indicate that there is a moderate to high risk of use error, or if a manufacturer is modifying a marketed device due to problems associated with use, particularly as corrective and preventive action (CAPA), then the manufacturer should perform appropriate human factors testing according to this guidance document.”
PR? LOL. Just a cheap scam. If anything the FDA will be even keener to reject Zalviso. They don't like leak theories threatening their good name.