R.J Steffens

Big Pharma: Where's the Risk Management?

On Jul 07 06:58 PM upndown1313 wrote:

> Sorry not impressed, either with oral-Lyn data that has been presented or the concept of a metformin chewing gum. Based on PhII results, PhIII will not get approval fro Oral-Lyn.
**********************...

Recent Oral-lyn Phase II results:

ADA Scientific Sessions 2008 "Insulin Analogue (Basal + Pre-Prandial Injection) vs. Human Insulin (Basal Injection + Prandial Oral Insulin (Generex Oral-lyn™) in Type-1 Diabetes Mellitus: A 372-Day Comparison"

Conclusion: "A regimen consisting of basal BID s.c. NPH and prandial orally-absorbed regular insulin (Generex Oral-lyn™) attained lower pre-meal glucose, HbA1c and Fru concentrations, than a regimen using basal and pre-prandial insulin analogue injections in Type-1 DM during a 372-day period."

professional.diabetes....

ADA Scientific Sessions 2007 "Comparison of Pre-prandial s.c. Regular Insulin vs Prandial Oral Insulin (Oral-lyn) in Adult Type-1 DM Subjects Receiving Basal s.c. Twice Daily Isophane Insulin (NPH)"

Conclusion: "Near normalization of parameters of DM metabolic control was achieved in all subjects. Direct comparison of HbA1c concentrations during CP demonstrate a superior effect of Generex Oral-lyn™ over subcutaneously injected regular insulin."

professional.diabetes....

"It is not like the inhaled insulin, so it doesn't get into the lungs,” said study investigator Philip Raskin, MD, professor of medicine at The University of Texas Southwestern Medical Center in Dallas. “People seem to like it, and it does seem to lower the blood sugar [the way] it is supposed to.”

Dr. Raskin is among the researchers involved in an international phase 3 study of 750 patients.

www.renalandurologynew.../

Genentech and Generex: New HER2/neu Research

"The small life science company is a fully owned subsidiary of Generex (GNBT) Biotechnology, and AE37 is currently in a large scale Phase II efficacy study."

Results of the Phase II are not expected for some time, but I just found an early indication that appears in an upcoming peer review from the CVDP. It is part of the final paragraph in this 8 page article:.

Expert Opin Biol Ther. 2009 Jan ;9

CD4(+) T cells in antitumor immunity: utility of an Ii-Key HER2/neu hybrid peptide vaccine (AE37).

"Based on early observations of patients enrolled in our Phase II AE37 trial, we are confident that this Ii-Key hybrid peptide will effectively stimulate an HER2/neu-specific immune response and will be an important component as we move forward with our plans to develop a multiepitope vaccine."

lib.bioinfo.pl/auth:Pe...

Four Drug Companies Vying for Diabetes Patients

Hi GreenClay,

Generex has conducted dose-response studies on their buccal insulin spray. Their patented Rapidmist delivery device has been found to bring precision dosing where each spray measures approx 1 Unit- of Oral-lyn human insulin from the first spray to the last. This allows for tight titration and is one of the main positive features of Oral-lyn. If you email the company at generex.com, they can send you the published data from the peer review (I believe the report was dated 2005).

There are no pills or syrup this far along in Phase testing. Oramed and Biocon have pills that are in very early Phase IIa, and one has a pill whose dose measures 8 mg and the other measures 10 mg. Both have tested their pills in a small handful of patients. I have followed both, and Emisphere also has promising platform technology, but has had difficulties in translating their research into a successful pill form.

Exubera was also measured in mg, and not the unit that diabetics, such as yourself, are familiar with. Their dosing was confusing and one of the many reasons for its lack of success.

An effective oral one unit dose should make things easier to calculate, depending on weight and carbs per meal. The low dose aspect would be a negative if many units are required for certain Type 1's. It is interesting that Generex is set to begin a diabetes preventive trial for those that are pre-diabetic or at risk of developling diabetes. This is similar to TrialNet, and is an area to watch for future developments.

ADA's 68th Scientific Sessions: A New Look at Insulin Therapy

"the downtrend was not accompanied by any vlome to speak of, and that is the only are that is comforting. ;)"

I'll redo that one! LOL. I was watching the Yankee game and typing.

The downtrend was not accompanied by any substantial volume, and that is an area we may draw comfort. ;)

ADA's 68th Scientific Sessions: A New Look at Insulin Therapy

I think part of the problem has to do with the overall state of the market and how that has caused some problems for baby microcap biotechs such as Generex. All of the news coming from Generex has been positive- from new Phase II data for Oral-lyn regarding a one year and 372 day study in Type 1 diabetes to the positive AE37 results that were just published with the USMCI and Walter Reed in the Journal of Clinical Oncology.

If we look at what they are doing in the clinic, which is what is important, we see they have one Phase III (Oral-lyn) and one Phase II (AE37 in breast cancer) underway for drugs targeting diabetes and cancer. Metcontrol Gum will probably be an Abbreviated Submission and their next trial looks set to begin. The wholly owned subsidiary, Antigen Express, also has two Phase I's that are dosing and three other vaccines (AE37 Combo with/and funded by Mary Crowley Medical, the melanoma vaccine with the Mayo Clinic, and the RNAi/Ii-key with Dr. Daopei Lu in Beijing) getting ready for human trials. The HIV DNA vaccine could pop up sometime in late 2008.

But financing also occured a couple of months back that may have added 30 mm shares to the outstanding total, and we will see in the 10K (Oct 2009) what the current OS total equals. That may have augmented the woes seen in the market, because there appears to be no bad news associated with the company or stock. Pending early approvals in the Middle East or Asia (China) for Oral-lyn may sneak up and lift the stock, as well as any other positive developments that the company announces.

Oral-lyn was featured on FOX News Health segment this week with Generex's Dr. Gerald Bernstein (former pres of the ADA):

www.foxnews.com/video2.../

I don't think delisting is a concern, because there is too much positive action occuring in the pipeline. They have 180 days to regain compliance and that should offer them enough room for announcing the type of news that will generate investor confidence. the downtrend was not accompanied by any vlome to speak of, and that is the only are that is comforting. ;)

Generex Biotechnology and the USMCI: Armed with Antigens in the War Against Breast Cancer

I notice that Antigen Express, the life science company that is developing AE37 with the USMCI, has now entered into a collaboration with the prestigous Mayo Clinic in a new trial of AE37 for a melanoma vaccine:

www.primenewswire.com/...

I feel this validates the technology platform of Ii-Key hybirds and reinforces my view that these peptide vaccines may represent aviable therapuetic option in the near future.

ADA's 68th Scientific Sessions: A New Look at Insulin Therapy

There was a link in a posted comment there to an article about the event that I was talking about as being well written. Now I don't see it. That's funny, but I guess I'll now take the compliment to myself. LOL.

Genentech: Britain's National Health Won't Pay for Avastin

"The biotechnology industry counters that they must be paid huge sums for small innovations to promote expensive research. Progress is in slow and steady steps, with very few dramatic breakthroughs. The industry claims that traditional cost-benefits should not apply."

Interesting article, thanks. In a somewhat related note, I wrote an article about two promising peptide based BC vaccines that are in development in collaboration with the United States Military Cancer Institute:

seekingalpha.com/artic...

The peptide vacines mentioned would cost much less than Herceptin or Avastin. E75 has shown survival benefit in a subgroup of a completed Phase II, and AE37 is now in a large efficacy Phase II trial and last week AE37 was also announced that it is to be trialed at the Mayo Clinic for a melanoma vaccine. AE37 is already in a prostate cancer vaccine trial at prestigous St Savas.

Continued success for Col Peoples and these vaccines would be great news, and give her2 expressing cancer patients MUCH less expensive treatment options for safe and effective treatment. These peptide vaccines have had no safety concerns and in the case of AE37, it was the first ever to have a robust immuno response without an adjuvant.

Hence, the "dramatic breakthroughs" may come from the smallest of companies, whose research is attracting the greatest of collaborators. If approved, they would shake up the entire vaccine and oncology field. With much lower projected costs, it should be a new treatment the British National Health Service and our own insurance companies would support.

Generex Biotechnology and the USMCI: Armed with Antigens in the War Against Breast Cancer

My quote: "Antigen Express entered into a Clinical Trial Agreement with HJF"

4th item down: www.hjf.org/research/u...

www.usmci.org/generex....

My quote: "data from researchers at the USMCI also appear to show the potential linking of E75 to a li-Key/HER2/neu MHC class II peptide which brings us to the subject of the other promising therpauetic vaccine in the USMCI's arsenal."

Here is some JUNE 2008 data showing potential E75 and Ii-Key binding: www.ncbi.nlm.nih.gov/p...

My quote: "Earlier this month at ASCO, Generex and the USMCI presented final Phase I data for AE37 in breast cancer / the investigators at the USMCI concluded that "AE37 is the first peptide vaccine derived from a tumor-associated antigen that elicits a robust immunologic response in cancer patients without the use of an immunoadjuvant.""

The ASCO abstract:
www.ascocancerfoundati...

I would bet that Genentech and Glasko pay close attention to the peptide vaccine initiative of Col. Peoples and the USMCI. Antigen Express and Generex are entered into an impressive collaboration.

www.medicalnewstoday.c...

Mannkind: Overlooked Biotech With Excellent Prospects (Part VI)

Daddy One: Upon FDA approval of TI, your eleven year old daughter would have to wait until she is 18 to take this inhalable insulin product. Mannkind is not studying TI on children, and Exubera was not approved for diabetics under age 18. The prevailing thought has been that their young lungs are not well suited for insulin delivery through this vital organ. Many would include adults in this category and that one of Mannkind's marketing hurdles which they will be hard pressed to overcome. It will take many more years of Phase IV testing for this barrier to be put to rest- 'if' long term post approval safety results prove positive. Oral-lyn, the buccal insulin spray that has been mentioned, is also a 'rapid' acting insulin with a short duration of action and has been successfully studied in Type 1 juveniles in 2007.

It appears that your daughter has a good dad on her side, so she is a lucky girl.

Ahithophel Weissberger has done a nice job presenting his opinions. But I don't think the market is pricing in a discount with the thought the FDA will not approve TI. I think the market feels even after approval, TI would require a massive and costly orientation effort and sales potential that do not match the high burn rate and cummalitive losses. Commercial success is not tested in a clinic. Unfortunatly, Exubera did not pave the way for inhalable delivery systems and burned downed the bridge. The marketing and orientation campaigns could restore some of what has been lost in the public percetption, but how much would a potential partner be willing to risk?

The efforts of these companies are impressive and worthy. Watching market reaction to Mannkind's Phase III studies will certainly be interesting. Maybe A.W. is right that this was a good time to buy, and all of the concerns do not matter when you take your POP and run. I'm not sure, and eagerly wait to see what a partner would pay and if one can be found. If I am not mistaken, Mannkind has an unused $500 mm SHELF available. This could help them 'go it alone". But continued dilution is a concern of all biotechs, and especially when the biotech burns close to $70 to $100 mm per quarter.

Thanks for your efforts, A.W. For this reader, you have provided a well written and interesting series of articles in an area I am very interested. Hopefully, in time, we will discuss the many novel insulin delivery options available to diabetics in a new age of care. At some point, those needles will be seen as a very unnatural way to deliver a protein and a relic of the medicinal past. These biotechnology companies, such as Mannkind and Generex, are trying to be one of the solutions and that is a respectable business goal.

Best of luck to us all, and especially the eleven year old diabetic.

Mannkind: Overlooked Biotech With Excellent Prospects (Part IV)

PS. I hope you delve into the GLP1 product. I also wanted to use my real name and step into the light. The psuedos sometimes fall into default and cause confusion. Neither of us are psuedoname types of people. Keep up the good work.

Mannkind: Overlooked Biotech With Excellent Prospects (Part IV)

Hi Ahithophel. You have interesting thoughts and I look foward to your articles. I wrote a few about another biotech- Generex. Terms for a partnership should be more lucrative considering Mannkind has brought Technosphere into Phase III alone. They have done a great job and efficacy seems clear. The main concern to a potential partner would be the odds of success for another "inhalable" insulin and perhaps long term safety issues. All of the data Mannkind presents could show could be very positive, but diabetics and endros may shun another inhalable until time erases doubt. Not all, but a percentage. Right now this large marketing hurdles. That would bring with it a huge orientation and educational need, on top of what already would be needed for any new delivery option.

The regional deals do remind me of Generex's position. They have signed distribution deals with Shreya Life Science in India and Bioton's Sci Gen in the China region. The terms are unique- with the partner paying regulatory costs for submission of approval, marketing, educational and be responsible for sales and distribution. They also provide the insulin crystals used to make their Oral-lyn buccal spray. (Oral-lyn is not an inhalable.) For the US and other large markets, we do not know if a more typical partnership will ensue. Generex has also brought there product to Phase III and for such a tiny firm this was a great accomplishment:

Friday, June 13, 2008

Biomed Notebook
By Ryan McBride
Oral insulin back in Worcester

<In the turbulent business of developing insulin taken orally rather than by injection, a Canadian biotech with R&D operations in Worcester hopes to pick up where such drug industry giants as Pfizer Inc. and Eli Lilly & Co. left off.

Generex Biotechnology Corp., a Toronto-based firm with a 12-person lab in Massachusetts, said last week it has launched a Phase 3 clinical trial of an oral insulin spray. Once seen as a Holy Grail of drug delivery, orally administered insulin has lost some luster because New York’s Pfizer, Eli Lilly of Indianapolis, Denmark’s Novo Nordisk AS have all pulled the plug on inhaled insulin programs in the past year.

No large U.S. drug companies have formed partnerships related to the oral insulin product with Generex — as Eli Lilly did with Cambridge biotech firm Alkermes Inc. — but Generex CEO Anna Gluskin indicated that her firm wouldn’t jump into a partnership without a big payday. “They are the ones that failed,” Gluskin said of Pfizer, Lilly and Novo. “So they really have to look at paying us a lot of money.”>

www.masshightech.com/s...

I hope they ALL succeed and give diabetics the choice they deserve. That would be a welcome change from a prison sentance of needles. It will be interesting to see how this plays out for Mannkind and what kind of terms they could now procure. From the strong efforts of Mannkind to the novel system developed by Generex, a new dawn in diabetic care is near.

Mannkind: Overlooked Biotech With Excellent Prospects (Part III)

Ahit- As a supportor of Mannkind, I must say your comments regarding a competitor appear out of line. Keep in mind that this small Generex firm has it's oral insulin research led by a former ADA President. So never underestimate the rest of the field. The debators were actually informative and presented a seemingly factual and educated alternate view. Your own analysis needs to stand on a foundation of factual DD, and nothing short. Anyway, thanks for the articles and please keep it positive. The overall writings on TI have been an interesting read.

Mannkind: Overlooked Biotech With Excellent Prospects (Part III)

You say: "I agree with you that it is likely that the FDA will want Mannkind to continue longer studies after it reaches the market, but that is a far cry from the FDA suggesting that ALL patients prescribed TI should undergo pulmonary tests."

I FIRMLY disagree, and I believe you will find any inhalable insulin product that the FDA approves will come with the condition that patients undergo pulmonary testing before and during treatment. This is costly and inconvienant. The FDA now has further and newer confirmatory evidence that lung function decreases in diabetes through the progression of the desease and hightened concern as a result of the Exubera's follies. They will be careful and safety comes before your $2.95 investment.

You say: "As for Generex: My information about them was taken straight out of their 10-Ks for 2005, 2006, and 2007. It speaks there clearly about the 200-patient trial and about their licensing revenue (although I believe that the licensing revenue was not recent)."

Nowhere in Generex's 10K's do they mention a 200 patient trial. You had earlier stated that "they have yet to show significant revenue -- only $67,000 in the last nine months (as of April 31, 2008), much of which is from licensing other patents of theirs." So if this licensing of patent revenue was "not recent", why would you have stated it was contained in the 9 month period ending April 31st? I will also inform you that Generex has never licensed a patent (?) and has never earned revenue in that way. Your due diligence appears to be make believe, and if you can show me this 200 person trial or revenue from licensing patents I will take my medicine. ;) Generex does have a very extensive patent portfolio for buccal delivery of insulin, peptides, and pain relief drugs such as morophine. They also have solid IP for Antigen Express's therapuetic vaccine candidates. They do not license patents but should soon license Antigen's Ii-Key technolgy. But not yet.

You say: "The amount that Generex is losing per quarter has to be taken in context of how much cash they have, which is around $25 million, much less than Mannkind. They are going to have liquidity problems far sooner than Mannkind at their respective burn rates." In your earlier response you had stated: "They may well be headed into bankruptcy (not tomorrow, but within the next 2 years) if they can't raise more money, and I don't know that they can."

The amount of cash Generex has one hand as of the quartley report issued last week is $38,450,627. That is approx 4 quarters worth of capital and their recent financing arrangement contains warrants that when exercised brings the company an additional $50+ mm plus. Generex also has a $150,000 million shelf approved by shareholders in May 2006 that is fully intact. So why would you state they may go "bankrupt" within two years? They have never had problems raising cash, and unlike Mannkind, have a manageable and respectable BURN RATE.

Mannkind'se burn rate was $99.2 million in the first quarter of '08. In the quarterly CC, CFO Pfeffer stated this burn rate will GROW in the next couple of qrtrs before falling again. He believes they have enough cash, $269.1 million, coupled with the availabiltyof a $350 line of credit from Mr Mann, to last until the end of 2009. But with a burn rate of $99.2 million in the first quarter of '08 and an anticipated increase over the next one to two quarters would leave under $100 mm by the end of the third quarter 2008. Even with the availabilty of the $350 line of credit he mentioned that is available from Mr Mann, how does he state the company is able to fund operations through the end of 2009?

There is a greater cause for concern for Mannkind's high spending ways and not for tiny Generex's modest $7 to $9 burn per quarter. Revenue from India or another country may also help augment their cash needs. Shreya already placed an order for $2.1 mm, so next quarter Generex has 25% of the quarter paid for. And as I illustrated, they do NOT have a current cash crises. Mannkind does presently have this grave concern associated with it's cash position as noted by Grant Zeng a senior analyst covering the biotechnology industry for Zacks Equity Research in a recent report:

We have a Sell rating on Mannkind based on our general negative view on the inhaled insulin segment. MNKD relies heavily on inhaled insulin program with a very weak pipeline. Also, the company is burning cash at a too high rate and cash position is a matter of great concern. www.istockanalyst.com/...~zoneid_Home.html

You state regarding the FDA's Draft Guidance: "But the parts that I quoted (about the necessary size and length of trials) were from the general part about ALL diabetes medications. I suggest that you reread it to ascertain that for yourself... I stand by my statement that Oral-lyn has ZERO chance of being approved in the U.S. or Europe until there is a major redoing of their Phase II and Phase III trials, which would take many years."

I am very familar with the guidance and you should read it closer. The part talking about the larger sized studies deals with Type "2" diabetes and Generex does not have ANY need to redesign their Phase III study protocol which is specifically for Type "1".

I understand you want your investment to increase in value and with a strong CEO you have reason for optimism, but TI will have one heck of a marketing disadvantage with diabetics weary of inhalable insulin and Mannkind is a company burning cash at an alarming rate. Blockbuster status would be needed to ever gain profitability and that is not the case for Oral-lyn. In one year Mannkind burned more cash then Generex has since it was founded. Mr Mann would need massive sales to recoup the losses and is this addressed in the research report you are trying to sell for $35?

Perhaps that is why you dismiss a smaller competitor with erroneous statements and gloss over Mannkinds own obstacles. PS. I never stated that India's standards matched the USA's. The FDA has been under hightened scrutiny for approving drugs that later exhibit safety problems (Avandia comes to mind.) I said that the other countries approving Oral-lyn speak well of it's safety and efficacy results in over 1,500 patients to date. MANY of their trials all had A1C levels as a protocol endpoint. Oral-lyn ALWAYS does well and also has a rapid (hence the name Rapidmist) onset and an even more natural "offset" compared to TI. Generex's CEO simply didn't have a CEO willing to BURN $1 B of his (her) own money. Themn again, Generex's CEO doesn't have to, since their are NO pulmonary tests needed for Oral-lyn.

Good luck with your investment and I hope you can carefully check assertions you make if you wish to present yourself as a credible source of information.

Mannkind: Overlooked Biotech With Excellent Prospects (Part III)

Hi Ahithophel- Perhaps I was unclear. I am talking about how a Type 2 diabetic is already experiencing decreased lung function and how that could be further effected by ANY inhalable insulin:

Reduced Lung Capacity Accelerates with Diabetes
March 26, 2008
March 26, 2008 (Newswise) — People who have diabetes encounter a faster loss of lung capacity than those who do not have diabetes, a finding that may have implications for the potential use of inhaled insulin, according to a study appearing in the April issue of Diabetes Care.

Reduced Lung Capacity in People with Diabetes

The lung research, part of a larger investigation known as the Atherosclerosis Risk in Communities (ARIC) study, confirmed previous suggestions that the lung is a target organ for diabetic injury and that lung abnormalities accelerate once diabetes takes hold. Previous research by the same authors established that decreased lung capacity precedes and may predict a diagnosis of diabetes. The new study is accompanied by an editorial that concludes that diminished lung function may contribute to diabetes morbidity and mortality.

Specifically, the study found that people with type 2 diabetes experienced a more rapid decline in forced vital capacity, the measure of how well the lungs fill with air, than people who did not have diabetes. Though all people experience a decline in forced vital capacity as they age, people with diabetes appear to undergo a more rapid loss that appears before the diabetes diagnosis and accelerates after the disease sets in.

This could be because high blood sugar levels stiffen the lung tissue, or because the fat tissue in the chest and abdomen may confine the lungs more in people with diabetes, explained the researchers. They concluded the study with advice to clinicians to “pay heightened attention to pulmonary function in their patients with type 2 diabetes.”

“Think of the lung as a crime victim who unwittingly abets the perpetrator to hasten the demise of the host,” wrote Dr. Connie Hsia, of the University of Texas Southwestern Medical Center’s Department of Internal Medicine, in an editorial accompanying the study. She suggested that the loss of pulmonary function could add
to diabetic morbidity and mortality, and raised concerns about the potential use of inhaled insulin, since it may “trigger or exacerbate pulmonary dysfunction.” www.dlife.com/diabetes...

There is not sufficient data to state that Technosphere would not trigger pulmonary dysfunction after prolonged usage and investors should be aware of the issue. The decreased lung function condition has been confirmed to be found in more Type 2 patients, so the FDA would be wise in asking for further studies and perhaps this could be accomplished in larger sized Phase IV's.

You also made a lot of incorrect statements regarding Generex. When did Generex conduct a study on 200 patients and what revenue did it earn licensing patents? The awnser would be never and none. The only revenue Generex reported has been for Glucose Rapidspray, which is a new OTC item. Revenue has not been declared yet in tiny Ecuador and sales have not commenced in India. India is not as rich as the USA, but has a growing middle class and is home to 1/3rd of the world's diabetics. Approval in India illustrates both the unique safety profile of Oral-lyn and the clarity of the efficacy within the dossier. Also, Oral-lyn HAS been measured by final A1c levels in many of the smaller tests (totaling over 1,500 diabetcs) and has also acheived superior results in this area vs standard injection. Here is one example: professional.diabetes....

Generex's partner in India, Shreya, did recently place an initial purchase order for 210,000 cannisters of Oral-lyn and sales are hoped to BEGIN by August. Also, Is Generex losing money "hand over first?" Their burn rate was approx $9 mm last quarter and averaged $7 mm the few periods before. So Mannkind loses as much in 1 quarter as Generex does in 9. The numbers are striking. Mannkind has 600 employees and Generex has close to 25. Mannkind has two products in Phase I one in Phase III. Generex has Metcontrol Gum slated to begin the next study (the first Phase I was in 2006) this summer to help complete the Abbreviated Drug Submission, a prostate cancer in Phase 1 with Phase II to start in 2008, an avian flu vaccine in Phase I with the next study with Dr John Treanor set to start in 2008, a collaboration with the United States Military Cancer Institute for a peptide breast cancer vaccine that is in a large Phase II, and Oral-lyn now in Phase III. Their HIV vaccine is set to begin Phase I in 2008 with Dr Bruce Walker, a combo peptide vaccine Phase I for 2008 is to be entirely funded by a cancer clinic and an rnai vaccine is set to begin in the Fall. That's not too shabby for the little penny stock. ;)

The FDA's new draft guidance you mention is specifically for diabetes drugs that have certain safety issues- such as some oral pills and "inhalable" insulin. They have a whole section for inhalable insulin. Oral-lyn is a simple buccal spray and is not effected by, nor mentioned within, this draft guidance. So while Technosphere will not be approved (as you state) for asthma patients, I would also say it will not be approved for smokers, children or anyone with a weakened pulmonary condition. They could all use Oral-lyn. This year Health Canada granted Oral-lyn Special Access Authorization for Type 1's under a certain condition. That sure doesn't sound like a joke.

You state: "I see no reason why the FDA would arbitrarily recommend pulmonary tests for Technosphere Insulin if it shows no problems in that regard."

If TI is approved, I believe the FDA will certainly recommend pulmonary testing for "diabetics" (not for "TI") to see if TI usage exhibits problems in that regard. If they don't, they are not doing their job.