Complete Yahoo post: PLEASE READ THIS BEFORE YOU SELL 22-Jul-09 06:34 pm
Today AP reported that Andy Burnham, the British Health Minister, said the UK could have up to 100,000 new cases of swine flu per day by the end of August. Currently we have seen only about 100,000 reported cases worldwide. If the cries of Andy Burnham are anywhere close to accurate, the world may be in for a huge health crisis. The UK won't be the only country that has big problems. The North American countries seem like a sure bet to join in. Japan is very worried. I'm sure many European countries, the former USSR countries, and China will get their share too.
One solution (or ameliorating factor for this problem) may be to use adjuvants. The Japanese Institute of Health has been doing considerable research in this area lately. Japan seems likely to try this. Ampligen (from Hemispherx BioPharma (HEB)), the same factor that is being put forth to combat Chronic Fatigue Syndrome (CFS), has proven to be the most successful adjuvant in trials with flu virus vaccines. It has made the flu vaccines up to 100 times more effective. The Japanese seem likely to use it as part of their flu vaccine (i.e. so they can use less "flu material" per vaccine shot). The US might even be forced to use it, even though the FDA has approved no adjuvant for use with flu vaccines yet.
How does this effect Ampligen for CFS approval? Ampligen has proven reasonably safe for use to combat CFS. It has also been shown to be effective. If the FDA approves Ampligen for use against CFS, it will be much easier for the US (if it has to) to approve the use of Ampligen with flu vaccine. It is my understanding that Ampligen can make the flu vaccine approximately 100 times more effective. If this is so, flu vaccine providers could use much less "flu material" to make up the vaccine (say 1/5 or even 1/10 as much). This would make the vaccine material the US received early go a much longer way. This might help avert a major pandemic. From the HEB studies for Ampligen for CFS, Ampligen is safe. From the Japanese studies, Ampligen is safe; and it is effective as a flu vaccine adjuvant. There does not appear to be a good reason not to use it.
If the FDA denies Ampligen approval for CFS, they will have a hard time approving it for use in a flu vaccine. If the Japanese use Ampligen successfully in their flu vaccines, the US will look extremely foolish if US citizens in the 100,000's or millions get swine flu because they were unable to get a vaccination in time. The FDA will likely want to leave their options open. This latest news from the UK Health Minister should tip the scales in favor of Ampligen approval for CFS (if there was a question in the first place).
There is very limited downside to Ampligen approval. It is apparently safe. It is reasonably effective. The only gripe that I have heard is the price. The FDA should realize their decision is not cast in stone. They can always re-evaluate. They should realize that they may be taking a bigger risk by not approving Ampligen for CFS.
Already there is an 80% chance of aproval for drugs that make it as far as Ampligen for CFS has. It will be an orphan drug. This pushes the odds of approval still higher. The need for Ampligen near term as a flu virus vaccine adjuvant may push Ampligen approval for CFS odds to nearly 100%. The approval decision is overdue by many weeks. The FDA should take action soon. Plus HEB will soon get a big step up in the use of Ampligen as a flu vaccine adjuvant. Both of these things should make HEB a lot more profitable in the very near future. This should positively impact the stock price.
